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1.
Ann Med ; 53(1): 103-116, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-33063540

RESUMO

BACKGROUND: Hyperglycaemia has emerged as an important risk factor for death in coronavirus disease 2019 (COVID-19). The aim of this study was to evaluate the association between blood glucose (BG) levels and in-hospital mortality in non-critically patients hospitalized with COVID-19. METHODS: This is a retrospective multi-centre study involving patients hospitalized in Spain. Patients were categorized into three groups according to admission BG levels: <140 mg/dL, 140-180 mg/dL and >180 mg/dL. The primary endpoint was all-cause in-hospital mortality. RESULTS: Of the 11,312 patients, only 2128 (18.9%) had diabetes and 2289 (20.4%) died during hospitalization. The in-hospital mortality rates were 15.7% (<140 mg/dL), 33.7% (140-180 mg) and 41.1% (>180 mg/dL), p<.001. The cumulative probability of mortality was significantly higher in patients with hyperglycaemia compared to patients with normoglycaemia (log rank, p<.001), independently of pre-existing diabetes. Hyperglycaemia (after adjusting for age, diabetes, hypertension and other confounding factors) was an independent risk factor of mortality (BG >180 mg/dL: HR 1.50; 95% confidence interval (CI): 1.31-1.73) (BG 140-180 mg/dL; HR 1.48; 95%CI: 1.29-1.70). Hyperglycaemia was also associated with requirement for mechanical ventilation, intensive care unit (ICU) admission and mortality. CONCLUSIONS: Admission hyperglycaemia is a strong predictor of all-cause mortality in non-critically hospitalized COVID-19 patients regardless of prior history of diabetes. KEY MESSAGE Admission hyperglycaemia is a stronger and independent risk factor for mortality in COVID-19. Screening for hyperglycaemia, in patients without diabetes, and early treatment of hyperglycaemia should be mandatory in the management of patients hospitalized with COVID-19. Admission hyperglycaemia should not be overlooked in all patients regardless prior history of diabetes.


Assuntos
Infecções por Coronavirus/mortalidade , Hiperglicemia/complicações , Pneumonia Viral/mortalidade , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Glicemia , Infecções por Coronavirus/sangue , Infecções por Coronavirus/complicações , Cuidados Críticos/estatística & dados numéricos , Feminino , Humanos , Hiperglicemia/mortalidade , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/sangue , Pneumonia Viral/complicações , Respiração Artificial/estatística & dados numéricos , Espanha/epidemiologia
2.
World J Gastroenterol ; 26(39): 6087-6097, 2020 Oct 21.
Artigo em Inglês | MEDLINE | ID: mdl-33132657

RESUMO

BACKGROUND: The coronavirus disease 2019 (COVID-19) is spreading rapidly around the world. Most critically ill patients have organ injury, including acute respiratory distress syndrome, acute kidney injury, cardiac injury, or liver dysfunction. However, few studies on acute gastrointestinal injury (AGI) have been reported in critically ill patients with COVID-19. AIM: To investigate the prevalence and outcomes of AGI in critically ill patients with COVID-19. METHODS: In this retrospective study, demographic data, laboratory parameters, AGI grades, clinical severity and outcomes were collected. The primary endpoints were AGI incidence and 28-d mortality. RESULTS: From February 10 to March 10 2020, 83 critically ill patients out of 1314 patients with COVID-19 were enrolled. Seventy-two (86.7%) patients had AGI during hospital stay, of these patients, 30 had AGI grade I, 35 had AGI grade II, 5 had AGI grade III, and 2 had AGI grade IV. The incidence of AGI grade II and above was 50.6%. Forty (48.2%) patients died within 28 days of admission. Multiple organ dysfunction syndrome developed in 58 (69.9%) patients, and septic shock in 16 (19.3%) patients. Patients with worse AGI grades had worse clinical variables, a higher incidence of septic shock and 28-d mortality. Sequential organ failure assessment (SOFA) scores (95%CI: 1.374-2.860; P < 0.001), white blood cell (WBC) counts (95%CI: 1.037-1.379; P = 0.014), and duration of mechanical ventilation (MV) (95%CI: 1.020-1.340; P = 0.025) were risk factors for the development of AGI grade II and above. CONCLUSION: The incidence of AGI was 86.7%, and hospital mortality was 48.2% in critically ill patients with COVID-19. SOFA scores, WBC counts, and duration of MV were risk factors for the development of AGI grade II and above. Patients with worse AGI grades had a higher incidence of septic shock and 28-d mortality.


Assuntos
Infecções por Coronavirus/fisiopatologia , Gastroenteropatias/fisiopatologia , Mortalidade Hospitalar , Pneumonia Viral/fisiopatologia , Lesão Renal Aguda/epidemiologia , Idoso , Betacoronavirus , China/epidemiologia , Infecções por Coronavirus/epidemiologia , Estado Terminal , Feminino , Gastroenteropatias/epidemiologia , Humanos , Incidência , Contagem de Leucócitos , Hepatopatias/epidemiologia , Masculino , Pessoa de Meia-Idade , Mortalidade , Insuficiência de Múltiplos Órgãos/epidemiologia , Escores de Disfunção Orgânica , Pandemias , Pneumonia Viral/epidemiologia , Prevalência , Respiração Artificial/estatística & dados numéricos , Síndrome do Desconforto Respiratório do Adulto/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Choque Séptico/epidemiologia
3.
Crit Care ; 24(1): 632, 2020 11 02.
Artigo em Inglês | MEDLINE | ID: mdl-33138839

RESUMO

BACKGROUND: COVID-19-related ARDS has unique features when compared with ARDS from other origins, suggesting a distinctive inflammatory pathogenesis. Data regarding the host response within the lung are sparse. The objective is to compare alveolar and systemic inflammation response patterns, mitochondrial alarmin release, and outcomes according to ARDS etiology (i.e., COVID-19 vs. non-COVID-19). METHODS: Bronchoalveolar lavage fluid and plasma were obtained from 7 control, 7 non-COVID-19 ARDS, and 14 COVID-19 ARDS patients. Clinical data, plasma, and epithelial lining fluid (ELF) concentrations of 45 inflammatory mediators and cell-free mitochondrial DNA were measured and compared. RESULTS: COVID-19 ARDS patients required mechanical ventilation (MV) for significantly longer, even after adjustment for potential confounders. There was a trend toward higher concentrations of plasma CCL5, CXCL2, CXCL10, CD40 ligand, IL-10, and GM-CSF, and ELF concentrations of CXCL1, CXCL10, granzyme B, TRAIL, and EGF in the COVID-19 ARDS group compared with the non-COVID-19 ARDS group. Plasma and ELF CXCL10 concentrations were independently associated with the number of ventilator-free days, without correlation between ELF CXCL-10 and viral load. Mitochondrial DNA plasma and ELF concentrations were elevated in all ARDS patients, with no differences between the two groups. ELF concentrations of mitochondrial DNA were correlated with alveolar cell counts, as well as IL-8 and IL-1ß concentrations. CONCLUSION: CXCL10 could be one key mediator involved in the dysregulated immune response. It should be evaluated as a candidate biomarker that may predict the duration of MV in COVID-19 ARDS patients. Targeting the CXCL10-CXCR3 axis could also be considered as a new therapeutic approach. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03955887.


Assuntos
Quimiocina CXCL10/metabolismo , Infecções por Coronavirus/complicações , Pneumonia Viral/complicações , Respiração Artificial/estatística & dados numéricos , Síndrome do Desconforto Respiratório do Adulto/etiologia , Síndrome do Desconforto Respiratório do Adulto/terapia , Adulto , Idoso , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Estudos Prospectivos , Fatores de Tempo
4.
Pan Afr Med J ; 35(Suppl 2): 136, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33193951

RESUMO

Introduction: SARS-CoV-2 is an emerging health threat outbreak. It may cause severe viral pneumonia with Acute Respiratory Distress Syndrome requiring critical care. Aim: to describe clinical features and outcomes of critically ill patients with SARS-CoV-2 infection. Methods: it was a retrospective study carried out in the medical ICU of Farhat Hached teaching hospital between March 11 and May 7, 2020. All consecutive patients with RT-PCR confirmed COVID-19 were included. Clinical characteristics and outcomes were collected by reviewing medical records. Results: during the study period, 10 critically ill patients with COVID-19 were enrolled. Mean age, 51.8±6.3 years; 8(80%), male. The most common comorbidities were; diabetes mellitus, 6(60%), obesity 2(20%), chronic kidney disease 2(20%) and hypertension 1(10%). Mean SAPS II, 23.2±1.8. The mean arterial oxygen partial pressure to fractional inspired oxygen ratio at admission was 136.2±79.7. Noninvasive mechanical ventilation was used in 4(40%) patients and 7(70%) received invasive mechanical ventilation. Tidal volume and PEEP were set respectively within the median [IQR] of, 5.7[5.6-6.3]ml/Kg and 10.7[6.5-11.7]cm H2O. Plateau pressure was monitored in the median [IQR] of 27.9 [25.9-28.5] cm H2O. Four patients received hydroxychloroquine alone and five hydroxychloroquine associated with an antiviral. Five patients developed respectively hyperactive (n=2), hypoactive (n=2) and mixed delirium (n=1). Mortality rate was at 70%. Conclusion: this study demonstrated a particular profile of COVID-19 in the critically ill as a severe presentation in aged males with comorbidities presenting with an ARDS-like and neurological impairment with poor prognosis. The only survivals seem to have benefited from noninvasive ventilatory support.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Estado Terminal/epidemiologia , Pneumonia Viral/epidemiologia , Antivirais/uso terapêutico , Doenças Cardiovasculares/epidemiologia , Comorbidade , Infecções por Coronavirus/tratamento farmacológico , Delírio/etiologia , Diabetes Mellitus/epidemiologia , Feminino , Mortalidade Hospitalar , Hospitais de Ensino/estatística & dados numéricos , Humanos , Hidroxicloroquina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Obesidade/epidemiologia , Pandemias , Pneumonia Viral/tratamento farmacológico , Prognóstico , Insuficiência Renal Crônica/epidemiologia , Respiração Artificial/estatística & dados numéricos , Síndrome do Desconforto Respiratório do Adulto/etiologia , Estudos Retrospectivos , Escala Psicológica Aguda Simplificada , Tunísia/epidemiologia
5.
PLoS One ; 15(11): e0241537, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33151983

RESUMO

The COVID-19 is rapidly scattering worldwide, and the number of cases in the Eastern Mediterranean Region is rising. Thus, there is a need for immediate targeted actions. We designed a longitudinal study in a hot outbreak zone to analyze the serial findings between infected patients for detecting temporal changes from February 2020. In a hospital-based open-cohort study, patients are followed from admission until one year from their discharge (the 1st, 4th, 12th weeks, and the first year). The patient recruitment phase finished at the end of August 2020, and the follow-up continues by the end of August 2021. The measurements included demographic, socio-economics, symptoms, health service diagnosis and treatment, contact history, and psychological variables. The signs improvement, death, length of stay in hospital were considered primary, and impaired pulmonary function and psychotic disorders were considered main secondary outcomes. Moreover, clinical symptoms and respiratory functions are being determined in such follow-ups. Among the first 600 COVID-19 cases, 490 patients with complete information (39% female; the average age of 57±15 years) were analyzed. Seven percent of these patients died. The three main leading causes of admission were: fever (77%), dry cough (73%), and fatigue (69%). The most prevalent comorbidities between COVID-19 patients were hypertension (35%), diabetes (28%), and ischemic heart disease (14%). The percentage of primary composite endpoints (PCEP), defined as death, the use of mechanical ventilation, or admission to an intensive care unit was 18%. The Cox Proportional-Hazards Model for PCEP indicated the following significant risk factors: Oxygen saturation < 80% (HR = 6.3; [CI 95%: 2.5,15.5]), lymphopenia (HR = 3.5; [CI 95%: 2.2,5.5]), Oxygen saturation 80%-90% (HR = 2.5; [CI 95%: 1.1,5.8]), and thrombocytopenia (HR = 1.6; [CI 95%: 1.1,2.5]). This long-term prospective Cohort may support healthcare professionals in the management of resources following this pandemic.


Assuntos
Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Adulto , Idoso , Betacoronavirus , Comorbidade , Feminino , Hospitalização , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Irã (Geográfico)/epidemiologia , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Pandemias , Alta do Paciente , Estudos Prospectivos , Respiração Artificial/estatística & dados numéricos
6.
PLoS One ; 15(11): e0240781, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33186355

RESUMO

BACKGROUND: This study aims to describe the epidemiology of COVID-19 patients in a Swiss university hospital. METHODS: This retrospective observational study included all adult patients hospitalized with a laboratory confirmed SARS-CoV-2 infection from March 1 to March 25, 2020. We extracted data from electronic health records. The primary outcome was the need to mechanical ventilation at day 14. We used multivariate logistic regression to identify risk factors for mechanical ventilation. Follow-up was of at least 14 days. RESULTS: 145 patients were included in the multivariate model, of whom 36 (24.8%) needed mechanical ventilation at 14 days. The median time from symptoms onset to mechanical ventilation was 9·5 days (IQR 7.00, 12.75). Multivariable regression showed increased odds of mechanical ventilation with age (OR 1.09 per year, 95% CI 1.03-1.16, p = 0.002), in males (OR 6.99, 95% CI 1.68-29.03, p = 0.007), in patients who presented with a qSOFA score ≥2 (OR 7.24, 95% CI 1.64-32.03, p = 0.009), with bilateral infiltrate (OR 18.92, 3.94-98.23, p<0.001) or with a CRP of 40 mg/l or greater (OR 5.44, 1.18-25.25; p = 0.030) on admission. Patients with more than seven days of symptoms on admission had decreased odds of mechanical ventilation (0.087, 95% CI 0.02-0.38, p = 0.001). CONCLUSIONS: This study gives some insight in the epidemiology and clinical course of patients admitted in a European tertiary hospital with SARS-CoV-2 infection. Age, male sex, high qSOFA score, CRP of 40 mg/l or greater and a bilateral radiological infiltrate could help clinicians identify patients at high risk for mechanical ventilation.


Assuntos
Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Respiração Artificial/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Betacoronavirus , Registros Eletrônicos de Saúde , Feminino , Hospitalização , Hospitais Universitários , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Pandemias , Estudos Retrospectivos , Fatores de Risco , Suíça , Centros de Atenção Terciária , Adulto Jovem
7.
BMC Med ; 18(1): 359, 2020 11 16.
Artigo em Inglês | MEDLINE | ID: mdl-33190637

RESUMO

BACKGROUND: Limited evidence exists on the role of glucose-lowering drugs in patients with COVID-19. Our main objective was to examine the association between in-hospital death and each routine at-home glucose-lowering drug both individually and in combination with metformin in patients with type 2 diabetes mellitus admitted for COVID-19. We also evaluated their association with the composite outcome of the need for ICU admission, invasive and non-invasive mechanical ventilation, or in-hospital death as well as on the development of in-hospital complications and a long-time hospital stay. METHODS: We selected all patients with type 2 diabetes mellitus in the Spanish Society of Internal Medicine's registry of COVID-19 patients (SEMI-COVID-19 Registry). It is an ongoing, observational, multicenter, nationwide cohort of patients admitted for COVID-19 in Spain from March 1, 2020. Each glucose-lowering drug user was matched with a user of other glucose-lowering drugs in a 1:1 manner by propensity scores. In order to assess the adequacy of propensity score matching, we used the standardized mean difference found in patient characteristics after matching. There was considered to be a significant imbalance in the group if a standardized mean difference > 10% was found. To evaluate the association between treatment and study outcomes, both conditional logit and mixed effect logistic regressions were used when the sample size was ≥ 100. RESULTS: A total of 2666 patients were found in the SEMI-COVID-19 Registry, 1297 on glucose-lowering drugs in monotherapy and 465 in combination with metformin. After propensity matching, 249 patients on metformin, 105 on dipeptidyl peptidase-4 inhibitors, 129 on insulin, 127 on metformin/dipeptidyl peptidase-4 inhibitors, 34 on metformin/sodium-glucose cotransporter 2 inhibitor, and 67 on metformin/insulin were selected. No at-home glucose-lowering drugs showed a significant association with in-hospital death; the composite outcome of the need of intensive care unit admission, mechanical ventilation, or in-hospital death; in-hospital complications; or long-time hospital stays. CONCLUSIONS: In patients with type 2 diabetes mellitus admitted for COVID-19, at-home glucose-lowering drugs showed no significant association with mortality and adverse outcomes. Given the close relationship between diabetes and COVID-19 and the limited evidence on the role of glucose-lowering drugs, prospective studies are needed.


Assuntos
Infecções por Coronavirus/mortalidade , Diabetes Mellitus Tipo 2/tratamento farmacológico , Inibidores da Dipeptidil Peptidase IV/uso terapêutico , Hipoglicemiantes/normas , Insulina/uso terapêutico , Metformina/uso terapêutico , Pneumonia Viral/mortalidade , Respiração Artificial/estatística & dados numéricos , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Betacoronavirus , Estudos de Coortes , Infecções por Coronavirus/complicações , Infecções por Coronavirus/terapia , Diabetes Mellitus Tipo 2/complicações , Quimioterapia Combinada , Feminino , Mortalidade Hospitalar , Hospitalização , Humanos , Hipoglicemiantes/uso terapêutico , Unidades de Terapia Intensiva , Tempo de Internação/estatística & dados numéricos , Modelos Logísticos , Masculino , Ventilação não Invasiva/estatística & dados numéricos , Pandemias , Pneumonia Viral/complicações , Pneumonia Viral/terapia , Estudos Prospectivos , Espanha
8.
Cochrane Database Syst Rev ; 10: CD013101, 2020 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-33045104

RESUMO

BACKGROUND: Corticosteroids are routinely given to children undergoing cardiac surgery with cardiopulmonary bypass (CPB) in an attempt to ameliorate the inflammatory response. Their use is still controversial and the decision to administer the intervention can vary by centre and/or by individual doctors within that centre. OBJECTIVES: This review is designed to assess the benefits and harms of prophylactic corticosteroids in children between birth and 18 years of age undergoing cardiac surgery with CPB. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and Conference Proceedings Citation Index-Science in June 2020. We also searched four clinical trials registers and conducted backward and forward citation searching of relevant articles. SELECTION CRITERIA: We included studies of prophylactic administration of corticosteroids, including single and multiple doses, and all types of corticosteroids administered via any route and at any time-point in the perioperative period. We excluded studies if steroids were administered therapeutically. We included individually randomised controlled trials (RCTs), with two or more groups (e.g. multi-drug or dose comparisons with a control group) but not 'head-to-head' trials without a placebo or a group that did not receive corticosteroids. We included studies in children, from birth up to 18 years of age, including preterm infants, undergoing cardiac surgery with the use of CPB. We also excluded studies in patients undergoing heart or lung transplantation, or both; studies in patients already receiving corticosteroids; in patients with abnormalities of the hypothalamic-pituitary-adrenal axis; and in patients given steroids at the time of cardiac surgery for indications other than cardiac surgery. DATA COLLECTION AND ANALYSIS: We used the Covidence systematic review manager to extract and manage data for the review. Two review authors independently assessed studies for inclusion, extracted data, and assessed risks of bias. We resolved disagreements by consensus or by consultation with a third review author. We assessed the certainty of evidence with GRADE. MAIN RESULTS: We found 3748 studies, of which 888 were duplicate records. Two studies had the same clinical trial registration number, but reported different populations and interventions. We therefore included them as separate studies. We screened titles and abstracts of 2868 records and reviewed full text reports for 84 studies to determine eligibility. We extracted data for 13 studies. Pooled analyses are based on eight studies. We reported the remaining five studies narratively due to zero events for both intervention and placebo in the outcomes of interest. Therefore, the final meta-analysis included eight studies with a combined population of 478 participants. There was a low or unclear risk of bias across the domains. There was moderate certainty of evidence that corticosteroids do not change the risk of in-hospital mortality (five RCTs; 313 participants; risk ratio (RR) 0.83, 95% confidence interval (CI) 0.33 to 2.07) for children undergoing cardiac surgery with CPB. There was high certainty of evidence that corticosteroids reduce the duration of mechanical ventilation (six RCTs; 421 participants; mean difference (MD) 11.37 hours lower, 95% CI -20.29 to -2.45) after the surgery. There was high-certainty evidence that the intervention probably made little to no difference to the length of postoperative intensive care unit (ICU) stay (six RCTs; 421 participants; MD 0.28 days lower, 95% CI -0.79 to 0.24) and moderate-certainty evidence that the intervention probably made little to no difference to the length of the postoperative hospital stay (one RCT; 176 participants; mean length of stay 22 days; MD -0.70 days, 95% CI -2.62 to 1.22). There was moderate certainty of evidence for no effect of the intervention on all-cause mortality at the longest follow-up (five RCTs; 313 participants; RR 0.83, 95% CI 0.33 to 2.07) or cardiovascular mortality at the longest follow-up (three RCTs; 109 participants; RR 0.40, 95% CI 0.07 to 2.46). There was low certainty of evidence that corticosteroids probably make little to no difference to children separating from CPB (one RCT; 40 participants; RR 0.20, 95% CI 0.01 to 3.92). We were unable to report information regarding adverse events of the intervention due to the heterogeneity of reporting of outcomes. We downgraded the certainty of evidence for several reasons, including imprecision due to small sample sizes, a single study providing data for an individual outcome, the inclusion of both appreciable benefit and harm in the confidence interval, and publication bias. AUTHORS' CONCLUSIONS: Corticosteroids  probably do not change the risk of mortality for children having heart surgery using CPB at any time point. They probably reduce the duration of postoperative ventilation in this context, but have little or no effect on the total length of postoperative ICU stay or total postoperative hospital stay. There was inconsistency in the adverse event outcomes reported which, consequently, could not be pooled. It is therefore impossible to provide any implications and policy-makers will be unable to make any recommendations for practice without evidence about adverse effects. The review highlighted the need for well-conducted RCTs powered for clinical outcomes to confirm or refute the effect of corticosteroids versus placebo in children having cardiac surgery with CPB. A core outcome set for adverse event reporting in the paediatric major surgery and intensive care setting is required.


Assuntos
Corticosteroides/uso terapêutico , Procedimentos Cirúrgicos Cardíacos/métodos , Ponte Cardiopulmonar/efeitos adversos , Inflamação/prevenção & controle , Adolescente , Corticosteroides/efeitos adversos , Viés , Procedimentos Cirúrgicos Cardíacos/mortalidade , Ponte Cardiopulmonar/mortalidade , Causas de Morte , Criança , Pré-Escolar , Dexametasona/uso terapêutico , Máquina Coração-Pulmão/efeitos adversos , Mortalidade Hospitalar , Humanos , Hidrocortisona/uso terapêutico , Lactente , Recém-Nascido , Inflamação/etiologia , Unidades de Terapia Intensiva Pediátrica/estatística & dados numéricos , Tempo de Internação , Metilprednisolona/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Respiração Artificial/estatística & dados numéricos
9.
Trials ; 21(1): 880, 2020 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-33106183

RESUMO

OBJECTIVES: We will investigate the effectiveness of high dose Interferon Beta 1a, compared to low dose Interferon Beta 1a (the base therapeutic regimen) in COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed) with moderate to severe disease TRIAL DESIGN: This is a single center, open label, randomized, controlled, 2-arm parallel group (1:1 ratio), clinical trial. PARTICIPANTS: The eligibility criteria in this study is: age ≥ 18 years, oxygen saturation (SPO2) ≤ 93% or respiratory rate ≥ 24, at least one of the following manifestation: radiation contactless body temperature ≥37.8, Cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission. The onset of the symptoms should be acute (≤ 14 days). The exclusion criteria include refusal to participate, using drugs with potential interaction with lopinavir/ritonavir or interferon-ß 1a, blood ALT/AST levels > 5 times the upper limit of normal on laboratory results, pregnant or lactating women, history of alcohol or drug addiction in the past 5 years, the patients who be intubated less than one hours after admission to hospital. This study will be undertaken at the Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences. INTERVENTION AND COMPARATOR: COVID- 19 confirmed patients (using the RT-PCR test or CT scan) will be randomly assigned to one of two groups. The intervention group (Arms1) will be treated with lopinavir / ritonavir (Kaletra) + high dose Interferon-ß 1a (Recigen) and the control group will be treated with lopinavir / ritonavir (Kaletra) + low dose Interferon-ß 1a (Recigen) (the base therapeutic regimen). Both groups will receive standard care consisting of the necessary oxygen support, non-invasive, or invasive mechanical ventilation. MAIN OUTCOMES: Primary outcome: Time to clinical improvement is our primary outcome measure. This is an improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever comes first. SECONDARY OUTCOMES: mortality from the date of randomization until the last day of the study which will be the day all of the patients have had at least one of the following outcomes: 1) Improvement of two points on a seven-category ordinal scale. 2) Discharge from the hospital 3) Death. Improvement of SPO2 during the hospitalization, duration of hospitalization from date of randomization until the date of hospital discharge or death, whichever comes first. The incidence of new mechanical ventilation uses from the date of randomization until the last day of the study and the duration of it will be extracted. Please note that we are trying to add further secondary outcomes and this section of the protocol is still evolving. RANDOMIZATION: Eligible patients with confirmed SARS-Cov-2 infections will be randomly assigned in a 1:1 ratio to two therapeutic arms using permuted, block-randomization to balance the number of patients allocated to each group. The permuted block (three or six patients per block) randomization sequence will be generated, using Package 'randomizeR' in R software version 3.6.1. and placed in individual sealed and opaque envelopes by the statistician. The investigator will enroll the patients and only then open envelopes to assign patients to the different treatment groups. This method of allocation concealment will result in minimum selection and confounding biases. BLINDING (MASKING): The present research is open-label (no masking) of patients and health care professionals who are undertaking outcome assessment of the primary outcome - time to clinical improvement. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Of the 100 patients randomised, 50 patients will be assigned to receive high dose Interferon beta-1a plus lopinavir/ritonavir (Kaletra), 50 patients will be assigned to receive low dose Interferon beta 1a plus lopinavir/ritonavir (Kaletra). TRIAL STATUS: Protocol version 1.2.1. Recruitment is finished, the start date of recruitment was on August 20th 2020, and the end date was on September 4th 2020. Last point of data collection will be the last day on which all of the 100 participants have had an outcome of clinical improvement or death, up to 14th days after hospitalization. TRIAL REGISTRATION: This study was registered with National Institutes of Health Clinical trials ( www.clinicaltrials.gov ; identification number NCT04521400, https://clinicaltrials.gov/ct2/show/NCT04521400 , registered August 18, 2020 and first available online August 20, 2020). FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Antivirais/uso terapêutico , Betacoronavirus/efeitos dos fármacos , Infecções por Coronavirus/tratamento farmacológico , Interferon beta-1a/uso terapêutico , Pneumonia Viral/tratamento farmacológico , Adulto , Antivirais/administração & dosagem , Estudos de Casos e Controles , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Relação Dose-Resposta a Droga , Combinação de Medicamentos , Humanos , Interferon beta-1a/administração & dosagem , Lopinavir/administração & dosagem , Lopinavir/uso terapêutico , Mortalidade/tendências , Avaliação de Resultados em Cuidados de Saúde , Pandemias , Alta do Paciente , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Respiração Artificial/estatística & dados numéricos , Ritonavir/administração & dosagem , Ritonavir/uso terapêutico
10.
BMJ Open Respir Res ; 7(1)2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33020114

RESUMO

INTRODUCTION: Smoking causes inflammation of the lung epithelium by releasing cytokines and impairing mucociliary clearance. Some studies have linked smoking with severity of illness of COVID-19 whereas others have found no such association. METHODS: This was a retrospective analysis of all adults hospitalised with COVID-19 from 9 March to 18 May 2020. RESULTS: 1173 patients met the study criteria. 837 patients never smoked whereas 336 patients were either current smokers or past smoker and were grouped together in smokers group. Patients in smokers group were more likely to be male and had higher incidence of underlying chronic obstructive pulmonary disease (19% vs 6%, p<0.001), HIV infection (11% vs 5%,p<0.001), cancer (11% vs 6%, p=0.005), congestive heart failure (15% vs 8%, p<0.001), coronary artery disease (15% vs 9%, p=0.3), chronic kidney disease (11% vs 8%, p=0.037) and end-stage renal disease (10% vs 6%, p=0.009) compared with non-smokers. Outcome analysis showed that smokers were more likely to develop critical illness requiring mechanical ventilation (47% vs 37% p=0.005). Univariate Cox model for survival analysis by smoking status showed that among smokers only current smokers had higher risk of death compared with never smokers (HR 1.61, 95% CI 1.22 to 2.12, p<0.001). In the multivariate approach, Cox model for the survival, female sex, young age, low serum lactate dehydrogenase and systemic steroid use were associated with overall improved survival. CONCLUSION: In our large single-centre retrospective database of patients hospitalised with COVID-19, smoking was associated with development of critical illness and higher likelihood of death.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Pacientes Internados/estatística & dados numéricos , Avaliação de Resultados da Assistência ao Paciente , Pneumonia Viral/epidemiologia , Respiração Artificial/estatística & dados numéricos , Fumar/epidemiologia , Idoso , Bases de Dados Factuais , Feminino , Hospitalização , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque/epidemiologia , Pandemias , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Análise de Sobrevida
11.
Medicine (Baltimore) ; 99(43): e22884, 2020 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-33120832

RESUMO

Delirium is a neuropsychiatric syndrome commonly encountered in critically ill patients, and systemic inflammation has been strongly implicated to underlie its pathophysiology. This study aimed to investigate the predictive value of the platelet-to-lymphocyte ratio (PLR) for delirium in the intensive care unit (ICU).In this retrospective observational study, we analyzed the clinical and laboratory data of 319 ICU patients from October 2016 to December 2017. Using the Locally Weighted Scatterplot Smoothing technique, a PLR knot was detected at a value of approximately 100. Logistic regression was used to investigate the association between the PLR and delirium.Of the 319 patients included in this study, 29 (9.1%) were diagnosed with delirium. In the delirium group, the duration of mechanical ventilation was significantly longer than that in the no-delirium group (40.2 ±â€Š65.5 vs. 19.9 ±â€Š26.5 hours, respectively; P < .001). A multiple logistic regression analysis showed that PLR > 100 (odds ratio [OR]: 1.003, 95% confidence interval [CI]: 1.001-1.005), age (OR: 2.76, 95% CI: 1.110-6.861), and the ratio of arterial oxygen partial pressure to the inspired oxygen fraction (OR: 0.996, 95% CI: 0.992-0.999) were independent predictors of delirium.In our study, a high PLR value on ICU admission was associated with a higher incidence of delirium. Owing to easy calculability, the PLR could be a useful delirium predictive index in ICUs, thereby enabling early interventions to be implemented.


Assuntos
Plaquetas/citologia , Estado Terminal/psicologia , Delírio/sangue , Linfócitos/citologia , Idoso , Monitorização Transcutânea dos Gases Sanguíneos/métodos , Estudos de Casos e Controles , China/epidemiologia , Delírio/diagnóstico , Delírio/epidemiologia , Delírio/fisiopatologia , Feminino , Humanos , Incidência , Inflamação/metabolismo , Inflamação/patologia , Inalação/fisiologia , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Oxigênio/análise , Valor Preditivo dos Testes , Respiração Artificial/estatística & dados numéricos , Estudos Retrospectivos
12.
Elife ; 92020 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-33044170

RESUMO

This study examined records of 2566 consecutive COVID-19 patients at five Massachusetts hospitals and sought to predict level-of-care requirements based on clinical and laboratory data. Several classification methods were applied and compared against standard pneumonia severity scores. The need for hospitalization, ICU care, and mechanical ventilation were predicted with a validation accuracy of 88%, 87%, and 86%, respectively. Pneumonia severity scores achieve respective accuracies of 73% and 74% for ICU care and ventilation. When predictions are limited to patients with more complex disease, the accuracy of the ICU and ventilation prediction models achieved accuracy of 83% and 82%, respectively. Vital signs, age, BMI, dyspnea, and comorbidities were the most important predictors of hospitalization. Opacities on chest imaging, age, admission vital signs and symptoms, male gender, admission laboratory results, and diabetes were the most important risk factors for ICU admission and mechanical ventilation. The factors identified collectively form a signature of the novel COVID-19 disease.


Assuntos
Betacoronavirus , Infecções por Coronavirus/terapia , Necessidades e Demandas de Serviços de Saúde , Pandemias , Pneumonia Viral/terapia , Adulto , Idoso , Área Sob a Curva , Índice de Massa Corporal , Comorbidade , Infecções por Coronavirus/epidemiologia , Diabetes Mellitus/epidemiologia , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Unidades de Terapia Intensiva/provisão & distribução , Masculino , Massachusetts/epidemiologia , Pessoa de Meia-Idade , Dinâmica não Linear , Pneumonia Viral/epidemiologia , Utilização de Procedimentos e Técnicas , Curva ROC , Respiração Artificial/estatística & dados numéricos , Fatores de Risco , Ventiladores Mecânicos/provisão & distribução
13.
JAMA ; 324(13): 1298-1306, 2020 10 06.
Artigo em Inglês | MEDLINE | ID: mdl-32876689

RESUMO

Importance: Coronavirus disease 2019 (COVID-19) is associated with severe lung damage. Corticosteroids are a possible therapeutic option. Objective: To determine the effect of hydrocortisone on treatment failure on day 21 in critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and acute respiratory failure. Design, Setting, and Participants: Multicenter randomized double-blind sequential trial conducted in France, with interim analyses planned every 50 patients. Patients admitted to the intensive care unit (ICU) for COVID-19-related acute respiratory failure were enrolled from March 7 to June 1, 2020, with last follow-up on June 29, 2020. The study intended to enroll 290 patients but was stopped early following the recommendation of the data and safety monitoring board. Interventions: Patients were randomized to receive low-dose hydrocortisone (n = 76) or placebo (n = 73). Main Outcomes and Measures: The primary outcome, treatment failure on day 21, was defined as death or persistent dependency on mechanical ventilation or high-flow oxygen therapy. Prespecified secondary outcomes included the need for tracheal intubation (among patients not intubated at baseline); cumulative incidences (until day 21) of prone position sessions, extracorporeal membrane oxygenation, and inhaled nitric oxide; Pao2:Fio2 ratio measured daily from day 1 to day 7, then on days 14 and 21; and the proportion of patients with secondary infections during their ICU stay. Results: The study was stopped after 149 patients (mean age, 62.2 years; 30.2% women; 81.2% mechanically ventilated) were enrolled. One hundred forty-eight patients (99.3%) completed the study, and there were 69 treatment failure events, including 11 deaths in the hydrocortisone group and 20 deaths in the placebo group. The primary outcome, treatment failure on day 21, occurred in 32 of 76 patients (42.1%) in the hydrocortisone group compared with 37 of 73 (50.7%) in the placebo group (difference of proportions, -8.6% [95.48% CI, -24.9% to 7.7%]; P = .29). Of the 4 prespecified secondary outcomes, none showed a significant difference. No serious adverse events were related to the study treatment. Conclusions and Relevance: In this study of critically ill patients with COVID-19 and acute respiratory failure, low-dose hydrocortisone, compared with placebo, did not significantly reduce treatment failure (defined as death or persistent respiratory support) at day 21. However, the study was stopped early and likely was underpowered to find a statistically and clinically important difference in the primary outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT02517489.


Assuntos
Anti-Inflamatórios/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Hidrocortisona/uso terapêutico , Pneumonia Viral/tratamento farmacológico , Respiração Artificial , Insuficiência Respiratória/terapia , Idoso , Anti-Inflamatórios/administração & dosagem , Betacoronavirus , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/terapia , Estado Terminal , Método Duplo-Cego , Término Precoce de Ensaios Clínicos , Feminino , Humanos , Hidrocortisona/administração & dosagem , Masculino , Pessoa de Meia-Idade , Oxigenoterapia , Pandemias , Pneumonia Viral/mortalidade , Pneumonia Viral/terapia , Respiração Artificial/estatística & dados numéricos , Insuficiência Respiratória/tratamento farmacológico , Insuficiência Respiratória/etiologia , Falha de Tratamento
14.
JAMA ; 324(13): 1307-1316, 2020 10 06.
Artigo em Inglês | MEDLINE | ID: mdl-32876695

RESUMO

Importance: Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung injury in these patients. Objective: To determine whether intravenous dexamethasone increases the number of ventilator-free days among patients with COVID-19-associated ARDS. Design, Setting, and Participants: Multicenter, randomized, open-label, clinical trial conducted in 41 intensive care units (ICUs) in Brazil. Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020. Final follow-up was completed on July 21, 2020. The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients. Interventions: Twenty mg of dexamethasone intravenously daily for 5 days, 10 mg of dexamethasone daily for 5 days or until ICU discharge, plus standard care (n =151) or standard care alone (n = 148). Main Outcomes and Measures: The primary outcome was ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Secondary outcomes were all-cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) at 48 hours, 72 hours, and 7 days. Results: A total of 299 patients (mean [SD] age, 61 [14] years; 37% women) were enrolled and all completed follow-up. Patients randomized to the dexamethasone group had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 2.26; 95% CI, 0.2-4.38; P = .04). At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004). There was no significant difference in the prespecified secondary outcomes of all-cause mortality at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days. Thirty-three patients (21.9%) in the dexamethasone group vs 43 (29.1%) in the standard care group experienced secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events. Conclusions and Relevance: Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days. Trial Registration: ClinicalTrials.gov Identifier: NCT04327401.


Assuntos
Anti-Inflamatórios/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Dexametasona/uso terapêutico , Pneumonia Viral/tratamento farmacológico , Respiração Artificial/estatística & dados numéricos , Síndrome do Desconforto Respiratório do Adulto/tratamento farmacológico , Administração Intravenosa , Idoso , Anti-Inflamatórios/efeitos adversos , Betacoronavirus , Brasil , Infecções Relacionadas a Cateter/epidemiologia , Infecções por Coronavirus/complicações , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/terapia , Dexametasona/efeitos adversos , Término Precoce de Ensaios Clínicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/complicações , Pneumonia Viral/mortalidade , Pneumonia Viral/terapia , Síndrome do Desconforto Respiratório do Adulto/etiologia
15.
JAMA ; 324(13): 1317-1329, 2020 10 06.
Artigo em Inglês | MEDLINE | ID: mdl-32876697

RESUMO

Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, Setting, and Participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and Relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707.


Assuntos
Anti-Inflamatórios/administração & dosagem , Infecções por Coronavirus/tratamento farmacológico , Hidrocortisona/administração & dosagem , Pneumonia Viral/tratamento farmacológico , Respiração Artificial/estatística & dados numéricos , Corticosteroides/uso terapêutico , Adulto , Anti-Inflamatórios/efeitos adversos , Betacoronavirus , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/terapia , Término Precoce de Ensaios Clínicos , Feminino , Humanos , Hidrocortisona/efeitos adversos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/mortalidade , Pneumonia Viral/terapia , Choque/tratamento farmacológico , Choque/etiologia , Resultado do Tratamento
16.
BMJ Glob Health ; 5(8)2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32863269

RESUMO

Respiratory viruses can be transmitted through contact, droplet and airborne routes. Viruses that are not naturally airborne may be aerosolised during medical procedures and transmitted to healthcare workers. Most resource-limited healthcare settings lack complex air handling systems to filter air and create pressure gradients that are necessary for minimising viral transmission. This review explores the association between ventilation and the transmission of respiratory viruses like SAR-CoV-2. When used appropriately, both natural and mechanical ventilation can decrease the concentration of viral aerosols, thereby reducing transmission. Although mechanical ventilation systems are more efficient, installation and maintenance costs limit their use in resource-limited settings, whereas the prevailing climate conditions make natural ventilation less desirable. Cost-effective hybrid systems of natural and mechanical ventilation may overcome these limitations.


Assuntos
Betacoronavirus , Infecções por Coronavirus , Ambiente Controlado , Pandemias , Pneumonia Viral , Respiração Artificial , África , Microbiologia do Ar , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/transmissão , Humanos , Pandemias/prevenção & controle , Isolamento de Pacientes , Quartos de Pacientes , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Pneumonia Viral/transmissão , Respiração Artificial/efeitos adversos , Respiração Artificial/estatística & dados numéricos
17.
PLoS One ; 15(9): e0239644, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32970757

RESUMO

The impact of the COVID-19 pandemic has been immense, while the epidemiology and pathophysiology remain unclear. Despite many casualties in many countries, there have been less than 1,000 deaths in Japan as of end of June, 2020. In this study, we analyzed the cases of COVID-19 patients admitted to our institution located in the Tokyo metropolitan area where the survival rate is higher than those in other cities in the world. Medical records of COVID-19 patients that were admitted to a single Japanese tertiary university hospital in the Tokyo metropolitan area between March 10th and June 2nd, 2020 were retrospectively reviewed. The identified COVID-19 cases were subdivided into two groups (severe and mild) depending on the need for mechanical ventilation. Those in the severe group required mechanical ventilation as opposed to those in the mild group. The data were analyzed using nonparametric tests expressed by median [interquartile range (IQR)]. A total of 45 COVID-19 patients were included, consisting of 22 severe cases (Group S) and 23 mild cases (Group M). Male sex (Group S, 95.5% vs. Group M, 56.5%, p<0.01), high body mass index (Group S, 24.89 [22.44-27.15] vs. Group M, 21.43 [19.05-23.75], p<0.01), and hyperlipidemia (Group S, 36.4% vs. Group M, 0%, p<0.01) were more seen in Group S. Five (22.7%) cases in Group S underwent extracorporeal membranous oxygenation (ECMO). On admission, lymphopenia, decreased albumin, and elevated fibrinogen, lactate dehydrogenase, transaminases, creatine kinase, C-reactive protein, and procalcitonin were observed in Group S. The median ICU and hospital stay were 13.5 [10.3-22.3] days and 23.0 [16.3-30.5] days, respectively, in Group S. As of June 28th, 2020, in Group S, 19 (86.4%) patients have survived, of which 17 (77.3%) were discharged, and 2 are still in treatments. Three died of multiple organ failure. All 23 patients in Group M have recovered. Male sex, high body mass index, and hyperlipidemia can be risk factors for severe COVID-19 pneumonia, and its overall short-term survival rate was between 77.3% and 86.4% in this study.


Assuntos
Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/terapia , Pneumonia Viral/diagnóstico , Pneumonia Viral/terapia , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Oxigenação por Membrana Extracorpórea/estatística & dados numéricos , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/epidemiologia , Prognóstico , Decúbito Ventral , Respiração Artificial/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Tóquio/epidemiologia , Resultado do Tratamento
18.
BMJ Open ; 10(9): e040729, 2020 09 25.
Artigo em Inglês | MEDLINE | ID: mdl-32978207

RESUMO

OBJECTIVES: Several physiological abnormalities that develop during COVID-19 are associated with increased mortality. In the present study, we aimed to develop a clinical risk score to predict the in-hospital mortality in COVID-19 patients, based on a set of variables available soon after the hospitalisation triage. SETTING: Retrospective cohort study of 516 patients consecutively admitted for COVID-19 to two Italian tertiary hospitals located in Northern and Central Italy were collected from 22 February 2020 (date of first admission) to 10 April 2020. PARTICIPANTS: Consecutive patients≥18 years admitted for COVID-19. MAIN OUTCOME MEASURES: Simple clinical and laboratory findings readily available after triage were compared by patients' survival status ('dead' vs 'alive'), with the objective of identifying baseline variables associated with mortality. These were used to build a COVID-19 in-hospital mortality risk score (COVID-19MRS). RESULTS: Mean age was 67±13 years (mean±SD), and 66.9% were male. Using Cox regression analysis, tertiles of increasing age (≥75, upper vs <62 years, lower: HR 7.92; p<0.001) and number of chronic diseases (≥4 vs 0-1: HR 2.09; p=0.007), respiratory rate (HR 1.04 per unit increase; p=0.001), PaO2/FiO2 (HR 0.995 per unit increase; p<0.001), serum creatinine (HR 1.34 per unit increase; p<0.001) and platelet count (HR 0.995 per unit increase; p=0.001) were predictors of mortality. All six predictors were used to build the COVID-19MRS (Area Under the Curve 0.90, 95% CI 0.87 to 0.93), which proved to be highly accurate in stratifying patients at low, intermediate and high risk of in-hospital death (p<0.001). CONCLUSIONS: The COVID-19MRS is a rapid, operator-independent and inexpensive clinical tool that objectively predicts mortality in patients with COVID-19. The score could be helpful from triage to guide earlier assignment of COVID-19 patients to the most appropriate level of care.


Assuntos
Betacoronavirus/isolamento & purificação , Infecções por Coronavirus , Cuidados Críticos , Procedimentos Clínicos , Pandemias , Pneumonia Viral , Medição de Risco/métodos , Triagem , Idoso , Infecções por Coronavirus/sangue , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/fisiopatologia , Cuidados Críticos/métodos , Cuidados Críticos/estatística & dados numéricos , Procedimentos Clínicos/organização & administração , Procedimentos Clínicos/normas , Feminino , Mortalidade Hospitalar , Hospitalização/estatística & dados numéricos , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Pneumonia Viral/sangue , Pneumonia Viral/diagnóstico , Pneumonia Viral/mortalidade , Pneumonia Viral/fisiopatologia , Prognóstico , Respiração Artificial/estatística & dados numéricos , Estudos Retrospectivos , Triagem/métodos , Triagem/estatística & dados numéricos
19.
BMJ Open ; 10(9): e040175, 2020 09 29.
Artigo em Inglês | MEDLINE | ID: mdl-32994259

RESUMO

INTRODUCTION: The course of the disease in SARS-CoV-2 infection in mechanically ventilated patients is unknown. To unravel the clinical heterogeneity of the SARS-CoV-2 infection in these patients, we designed the prospective observational Maastricht Intensive Care COVID cohort (MaastrICCht). We incorporated serial measurements that harbour aetiological, diagnostic and predictive information. The study aims to investigate the heterogeneity of the natural course of critically ill patients with a SARS-CoV-2 infection. METHODS AND ANALYSIS: Mechanically ventilated patients admitted to the intensive care with a SARS-CoV-2 infection will be included. We will collect clinical variables, vital parameters, laboratory variables, mechanical ventilator settings, chest electrical impedance tomography, ECGs, echocardiography as well as other imaging modalities to assess heterogeneity of the course of a SARS-CoV-2 infection in critically ill patients. The MaastrICCht is also designed to foster various other studies and registries and intends to create an open-source database for investigators. Therefore, a major part of the data collection is aligned with an existing national intensive care data registry and two international COVID-19 data collection initiatives. Additionally, we create a flexible design, so that additional measures can be added during the ongoing study based on new knowledge obtained from the rapidly growing body of evidence. The spread of the COVID-19 pandemic requires the swift implementation of observational research to unravel heterogeneity of the natural course of the disease of SARS-CoV-2 infection in mechanically ventilated patients. Our study design is expected to enhance aetiological, diagnostic and prognostic understanding of the disease. This paper describes the design of the MaastrICCht. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the medical ethics committee (Medisch Ethische Toetsingscommissie 2020-1565/3 00 523) of the Maastricht University Medical Centre+ (Maastricht UMC+), which will be performed based on the Declaration of Helsinki. During the pandemic, the board of directors of Maastricht UMC+ adopted a policy to inform patients and ask their consent to use the collected data and to store serum samples for COVID-19 research purposes. All study documentation will be stored securely for fifteen years after recruitment of the last patient. The results will be published in peer-reviewed academic journals, with a preference for open access journals, while particularly considering deposition of the manuscripts on a preprint server early. TRIAL REGISTRATION NUMBER: The Netherlands Trial Register (NL8613).


Assuntos
Infecções por Coronavirus , Cuidados Críticos/métodos , Estado Terminal , Imagem Multimodal/métodos , Pandemias , Pneumonia Viral , Respiração Artificial , Betacoronavirus/isolamento & purificação , Estudos de Coortes , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/fisiopatologia , Infecções por Coronavirus/terapia , Estado Terminal/epidemiologia , Estado Terminal/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Pneumonia Viral/epidemiologia , Pneumonia Viral/fisiopatologia , Pneumonia Viral/terapia , Prognóstico , Sistema de Registros/estatística & dados numéricos , Respiração Artificial/métodos , Respiração Artificial/estatística & dados numéricos , Índice de Gravidade de Doença
20.
Cochrane Database Syst Rev ; 9: CD013708, 2020 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-32870512

RESUMO

BACKGROUND: Supplemental oxygen is frequently administered to patients with acute respiratory distress syndrome (ARDS), including ARDS secondary to viral illness such as coronavirus disease 19 (COVID-19). An up-to-date understanding of how best to target this therapy (e.g. arterial partial pressure of oxygen (PaO2) or peripheral oxygen saturation (SpO2) aim) in these patients is urgently required. OBJECTIVES: To address how oxygen therapy should be targeted in adults with ARDS (particularly ARDS secondary to COVID-19 or other respiratory viruses) and requiring mechanical ventilation in an intensive care unit, and the impact oxygen therapy has on mortality, days ventilated, days of catecholamine use, requirement for renal replacement therapy, and quality of life. SEARCH METHODS: We searched the Cochrane COVID-19 Study Register, CENTRAL, MEDLINE, and Embase from inception to 15 May 2020 for ongoing or completed randomized controlled trials (RCTs). SELECTION CRITERIA: Two review authors independently assessed all records in accordance with standard Cochrane methodology for study selection. We included RCTs comparing supplemental oxygen administration (i.e. different target PaO2 or SpO2 ranges) in adults with ARDS and receiving mechanical ventilation in an intensive care setting. We excluded studies exploring oxygen administration in patients with different underlying diagnoses or those receiving non-invasive ventilation, high-flow nasal oxygen, or oxygen via facemask. DATA COLLECTION AND ANALYSIS: One review author performed data extraction, which a second review author checked. We assessed risk of bias in included studies using the Cochrane 'Risk of bias' tool. We used the GRADE approach to judge the certainty of the evidence for the following outcomes; mortality at longest follow-up, days ventilated, days of catecholamine use, and requirement for renal replacement therapy. MAIN RESULTS: We identified one completed RCT evaluating oxygen targets in patients with ARDS receiving mechanical ventilation in an intensive care setting. The study randomized 205 mechanically ventilated patients with ARDS to either conservative (PaO2 55 to 70 mmHg, or SpO2 88% to 92%) or liberal (PaO2 90 to 105 mmHg, or SpO2 ≥ 96%) oxygen therapy for seven days. Overall risk of bias was high (due to lack of blinding, small numbers of participants, and the trial stopping prematurely), and we assessed the certainty of the evidence as very low. The available data suggested that mortality at 90 days may be higher in those participants receiving a lower oxygen target (odds ratio (OR) 1.83, 95% confidence interval (CI) 1.03 to 3.27). There was no evidence of a difference between the lower and higher target groups in mean number of days ventilated (14.0, 95% CI 10.0 to 18.0 versus 14.5, 95% CI 11.8 to 17.1); number of days of catecholamine use (8.0, 95% CI 5.5 to 10.5 versus 7.2, 95% CI 5.9 to 8.4); or participants receiving renal replacement therapy (13.7%, 95% CI 5.8% to 21.6% versus 12.0%, 95% CI 5.0% to 19.1%). Quality of life was not reported. AUTHORS' CONCLUSIONS: We are very uncertain as to whether a higher or lower oxygen target is more beneficial in patients with ARDS and receiving mechanical ventilation in an intensive care setting. We identified only one RCT with a total of 205 participants exploring this question, and rated the risk of bias as high and the certainty of the findings as very low. Further well-conducted studies are urgently needed to increase the certainty of the findings reported here. This review should be updated when more evidence is available.


Assuntos
Betacoronavirus , Infecções por Coronavirus/complicações , Unidades de Terapia Intensiva , Oxigênio/administração & dosagem , Pneumonia Viral/complicações , Respiração Artificial , Síndrome do Desconforto Respiratório do Adulto/terapia , Viés , Catecolaminas/uso terapêutico , Tratamento Conservador , Humanos , Razão de Chances , Pandemias , Terapia de Substituição Renal/estatística & dados numéricos , Respiração Artificial/estatística & dados numéricos , Síndrome do Desconforto Respiratório do Adulto/mortalidade , Síndrome do Desconforto Respiratório do Adulto/virologia , Autoimagem , Fatores de Tempo
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