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1.
Med. clín (Ed. impr.) ; 155(5): 191-196, sept. 2020. tab, graf
Artigo em Inglês | IBECS | ID: ibc-190153

RESUMO

OBJECTIVE: The purpose of our study was to assess organ function in 102 patients with severe COVID-19 infections, using retrospective clinical analysis. MATERIAL AND METHODS: A retrospective analysis was conducted on 102 patients with severe COVID-19 infections. The patients were divided into a survival group (n = 73) and a non-survival group (n = 29) according to their prognosis. The age, sex, underlying diseases, clinical laboratory data within 48 h (routine blood tests, ALT, AST, TBIL, ALB, BUN, CR, D-Dimer, PT, APTT, FIB, F VIII:C, CK-MB, CK, and LDH), and ventilation status were collected. The organ functions of these severe COVID-19 patients were assessed by comparing the differences between the two groups. RESULTS: AST, BUN, CR, CK-MB, LDH, and CK in the non-survival group were higher than those in the survival group, and the differences were statistically significant (P < 0.05). D-Dimer, PT, FIB, and F VIII:C in the non-survival group were higher than the values observed in the survival group, and the differences were statistically significant (P < 0.05). PLT, AST, BUN, CR, D-Dimer, PT, FIB, F VIII:C, CK-MB, CK, and LDH predicted the area under the ROC curve (AUC) of the COVID19 endpoint events and were 0.721, 0.854, 0.867, 0.757, 0.699, 0.679, 0.715, 0.811, 0.935, and 0.802, respectively. CONCLUSION: The results showed that there were different degrees of damage to the liver, kidneys, blood coagulation, and heart function in the non-survival group. In addition, PLT, AST, BUN, CR, D-Dimer, PT, FIB, F VIII:C, CK-MB, CK, and LDH had value in evaluating disease prognosis


OBJETIVO: Nuestro estudio tiene como objetivo evaluar la función del órgano en 102 pacientes con infección grave COVID-19 mediante análisis clínicos retrospectivos. MATERIALES Y MÉTODOS: Análisis retrospectivo de 102 pacientes con infección grave COVID-19. Los pacientes se dividieron en grupo de supervivencia (n=73) y grupo de no supervivencia (n = 29) según la pre-fase. Edad, género, enfermedades subyacentes, datos de laboratorio clínico dentro de las 48h (prueba de sangre de rutina, ALT, AST, TBIL, ALB, BUN, CR, dímero D, PT, APTT, FIB, F VIII: C, CK-MB, CK y LDH), y el estado de ventilación. Al comparar las diferencias entre los 2 grupos, se evaluó la función orgánica de estos pacientes graves con COVID-19. RESULTADOS: AST, BUN, CR, CK-MB, LDH y CK fueron todos más altos que el grupo de supervivencia en el grupo no sobreviviente, con una diferencia estadísticamente significativa (p < 0,05). Dímero D, PT, FIB y F VIII: C fueron mayores que el grupo de supervivencia en el grupo de no supervivencia, y la diferencia fue estadísticamente significativa (p < 0,05). PLT, AST, BUN, CR, dímero D, PT, FIB, F VIII: C, CK-MB, CK y LDH predijeron el área de curva inferior ROC (AUC) del evento final COVID-19, a 0,721, 0,854, 0,867, 0,757, 0,699, 0,679, 0,715, 0,811, 0,935 y 0,802, respectivamente. CONCLUSIÓN: Los resultados mostraron que el grupo de no supervivencia tenía diferentes grados de daño al hígado, riñón, coagulación y función cardíaca. Además, PLT, AST, BUN, CR, dímero D, PT, FIB, F VIII:C, CK-MB, CK y LDH tienen valor en la evaluación del pronóstico de la enfermedad


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Infecções por Coronavirus/fisiopatologia , Pneumonia Viral/fisiopatologia , Taxa de Sobrevida , Índice de Gravidade de Doença , Betacoronavirus , Prognóstico , Estudos Retrospectivos , Infecções por Coronavirus/mortalidade , Ventilação não Invasiva , Curva ROC , Escores de Disfunção Orgânica
2.
Eur J Immunol ; 50(9): 1283-1294, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32910469

RESUMO

Studies on the interactions between SARS-CoV-2 and humoral immunity are fundamental to elaborate effective therapies including vaccines. We used polychromatic flow cytometry, coupled with unsupervised data analysis and principal component analysis (PCA), to interrogate B cells in untreated patients with COVID-19 pneumonia. COVID-19 patients displayed normal plasma levels of the main immunoglobulin classes, of antibodies against common antigens or against antigens present in common vaccines. However, we found a decreased number of total and naïve B cells, along with decreased percentages and numbers of memory switched and unswitched B cells. On the contrary, IgM+ and IgM- plasmablasts were significantly increased. In vitro cell activation revealed that B lymphocytes showed a normal proliferation index and number of dividing cells per cycle. PCA indicated that B-cell number, naive and memory B cells but not plasmablasts clustered with patients who were discharged, while plasma IgM level, C-reactive protein, D-dimer, and SOFA score with those who died. In patients with pneumonia, the derangement of the B-cell compartment could be one of the causes of the immunological failure to control SARS-Cov2, have a relevant influence on several pathways, organs and systems, and must be considered to develop vaccine strategies.


Assuntos
Anticorpos Antivirais/sangue , Linfócitos B/imunologia , Betacoronavirus/patogenicidade , Infecções por Coronavirus/imunologia , Isotipos de Imunoglobulinas/sangue , Pulmão/imunologia , Pneumonia Viral/imunologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Antivirais/classificação , Linfócitos B/virologia , Betacoronavirus/imunologia , Proteína C-Reativa/imunologia , Estudos de Casos e Controles , Proliferação de Células , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/patologia , Infecções por Coronavirus/virologia , Estudos Transversais , Citocinas/genética , Citocinas/imunologia , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio/imunologia , Humanos , Imunidade Humoral , Memória Imunológica , Pulmão/patologia , Pulmão/virologia , Ativação Linfocitária , Contagem de Linfócitos , Masculino , Pessoa de Meia-Idade , Escores de Disfunção Orgânica , Pandemias , Pneumonia Viral/mortalidade , Pneumonia Viral/patologia , Pneumonia Viral/virologia , Cultura Primária de Células , Índice de Gravidade de Doença , Análise de Sobrevida
3.
Zhonghua Wei Zhong Bing Ji Jiu Yi Xue ; 32(8): 943-946, 2020 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-32912407

RESUMO

OBJECTIVE: To analyze the clinical characteristics of septic shock caused by upper and lower gastrointestinal perforation. METHODS: Clinical data of patients with septic shock due to gastrointestinal perforation admitted to the department of critical care medicine of the Affiliated Hospital of Guizhou Medical University from January 2018 to December 2019 were analyzed retrospectively. The general information; procalcitonin (PCT), acute physiology and chronic health evaluation II (APACHE II) and sequential organ failure assessment (SOFA) scores during the first 24 hours in intensive care unit (ICU); results of ascites culture during the first 72 hours in ICU; the maximum dosage and total time of norepinephrine (NE) in ICU; mechanical ventilation time, the length of ICU stay, occurrence of acute kidney injury (AKI), continuous renal replacement therapy (CRRT) and 28-day mortality were collected. The patients were divided into upper gastrointestinal tract group (stomach and duodenum) and lower gastrointestinal tract group (jejunum, ileum, appendix, colon and rectum), with a boundary of Treitz. The clinical features between the two groups were compared. RESULTS: There were 33 patients in the upper gastrointestinal tract group and 30 patients in the lower gastrointestinal tract group. There was no significant difference in gender and age between the two groups. The main pathogens in the ascites cultures in the upper gastrointestinal tract group were Candida albicans (45.5%), Enterococcus faecalis (18.2%) and Escherichia coli (18.2%). Escherichia coli (46.2%) and Enterococcus faecalis (30.8%) were the main pathogens in the lower gastrointestinal tract group. There were significant differences in PCT, the length of ICU stay, mechanical ventilation time, the maximum dosage and total time of NE between the upper gastrointestinal tract group and lower gastrointestinal tract group [PCT (µg/L): 17.69 (3.83, 26.62) vs. 32.82 (4.21, 100.00), the length of ICU stay (hours): 149.0 (102.5, 302.0) vs. 115.5 (30.8, 214.5), mechanical ventilation time (hours): 106.0 (41.5, 183.0) vs. 57.5 (25.0, 122.3), the maximum dosage of NE (µg×kg-1×min-1): 1.2 (0.5, 2.0) vs. 0.7 (0.5, 1.2), the total time of NE (hours): 72.0 (21.0, 145.0) vs. 26.5 (18.0, 80.5), all P < 0.05], while there was no statistically differences in APACHE II or SOFA scores [APACHE II: 30.0 (24.5, 35.0) vs. 28.0 (25.0, 33.5), SOFA: 10.67±4.14 vs. 9.50±3.33, both P > 0.05]. Compared with the lower gastrointestinal tract group, patients in the upper gastrointestinal tract group were more likely to have AKI (78.8% vs. 53.3%, P < 0.05) and require CRRT (39.4% vs. 16.7%, P < 0.05), but there was no significant difference in the 28-day mortality (39.4% vs. 43.3%, P > 0.05). CONCLUSIONS: The clinical characteristics of septic shock caused by upper and lower gastrointestinal perforation are not the same. Patients with septic shock caused by upper gastrointestinal perforation are more likely to suffer from fungal infection, with more severe shock, more likely to have AKI and require CRRT, and significantly longer mechanical ventilation and the length of ICU stay. While patients with septic shock caused by lower gastrointestinal perforation showed higher PCT.


Assuntos
Perfuração Intestinal , Choque Séptico , APACHE , Humanos , Unidades de Terapia Intensiva , Escores de Disfunção Orgânica , Estudos Retrospectivos
4.
Emerg Med Clin North Am ; 38(4): 807-818, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32981619

RESUMO

Sepsis care has evolved significantly since the initial early goal-directed therapy (EGDT) trials. Early fluid resuscitation, source control, and antibiotic therapy remain cornerstones of care but overall understanding is more nuanced, particularly regarding fluid selection, vasopressors, and inotropic support. Timely nutrition therapy and ventilatory support tend to receive less attention but also are important. Recent research has explored immunomodulation, ß-blockade, and vitamin supplementation. A renewed emphasis on early, aggressive resuscitation reaffirms the importance of emergency medicine providers knowledgeable and skilled in sepsis management.


Assuntos
Ressuscitação/métodos , Sepse/terapia , Angiotensina II/uso terapêutico , Antibacterianos/uso terapêutico , Antioxidantes/uso terapêutico , Ácido Ascórbico/uso terapêutico , Glicemia/análise , Pressão Sanguínea , Cardiomiopatias/etiologia , Cardiomiopatias/terapia , Cardiotônicos/uso terapêutico , Estado Terminal , Serviço Hospitalar de Emergência , Nutrição Enteral , Hidratação , Glucocorticoides/uso terapêutico , Hemodinâmica , Humanos , Escores de Disfunção Orgânica , Ensaios Clínicos Controlados Aleatórios como Assunto , Respiração Artificial , Vasoconstritores/uso terapêutico
5.
Clín. investig. ginecol. obstet. (Ed. impr.) ; 47(3): 118-127, jul.-sept. 2020. tab
Artigo em Espanhol | IBECS | ID: ibc-191031

RESUMO

La infección causada por el nuevo coronavirus SARS-CoV-2 (COVID-19) representa actualmente una de las mayores emergencias sanitarias a nivel mundial. La aparición de una nueva infección potencialmente grave y la situación de pandemia actual ha implicado importantes ajustes en la práctica clínica en medicina materno-fetal. Aunque no parece existir una mayor afectación o susceptibilidad al virus de las mujeres embarazadas respecto la población general, existen aspectos específicos ligados a la gestación que deben tenerse en cuenta de cara al diagnóstico y manejo de la COVID-19 en pacientes embarazadas. En el siguiente documento se exponen las recomendaciones y el protocolo de actuación ante la infección por COVID-19 durante el embarazo desarrollado en nuestro centro, basado en la evidencia científica disponible hasta la fecha y las principales recomendaciones internacionales


The severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) disease (COVID-19) has caused a large global outbreak and has had a major impact on health systems and societies worldwide. The generation of knowledge about the disease has occurred almost as fast as its global expansion. Very few studies have reported on the effects of the infection on maternal health, since its onset. The mother and foetus do not seem to be at particularly high risk. Nevertheless, obstetrics and maternal-foetal medicine practice have made profound changes in order to adapt to the pandemic. In addition, there are aspects specific to COVID-19 and gestation that should be known by specialists. In this review an evidenced-based protocol is presented for the management of COVID-19 in pregnancy


Assuntos
Humanos , Masculino , Feminino , Gravidez , Betacoronavirus , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Complicações Infecciosas na Gravidez/prevenção & controle , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/virologia , Pneumonia Viral/virologia , Complicações Infecciosas na Gravidez/virologia , Espanha , Escores de Disfunção Orgânica , Obstetrícia/métodos , Período Pós-Parto
6.
Pediatrics ; 146(4)2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32978294

RESUMO

BACKGROUND AND OBJECTIVES: The identification of life-threatening infection in febrile children presenting to the emergency department (ED) remains difficult. The quick Sequential Organ Failure Assessment (qSOFA) was only derived for adult populations, implying an urgent need for pediatric scores. We developed and validated a novel, adapted qSOFA score (Liverpool quick Sequential Organ Failure Assessment [LqSOFA]) and compared its performance with qSOFA, Pediatric Early Warning Score (PEWS), and National Institute for Health and Care Excellence (NICE) high-risk criteria in predicting critical care (CC) admission in febrile children presenting to the ED. METHODS: The LqSOFA (range, 0-4) incorporates age-adjusted heart rate, respiratory rate, capillary refill, and consciousness level on the Alert, Voice, Pain, Unresponsive scale. The primary outcome was CC admission within 48 hours of ED presentation, and the secondary outcome was sepsis-related mortality. LqSOFA, qSOFA, PEWS, and NICE high-risk criteria scores were calculated, and performance characteristics, including area under the receiver operating characteristic curve, were calculated for each score. RESULTS: In the initial (n = 1121) cohort, 47 CC admissions (4.2%) occurred, and in the validation (n = 12 241) cohort, 135 CC admissions (1.1%) occurred, and there were 5 sepsis-related deaths. In the validation cohort, LqSOFA predicted CC admission with an area under the receiver operating characteristic curve of 0.81 (95% confidence interval [CI], 0.76 to 0.86), versus qSOFA (0.66; 95% CI, 0.60 to 0.71), PEWS (0.93; 95% CI, 0.90 to 0.95), and NICE high-risk criteria (0.81; 95% CI, 0.78 to 0.85). For predicting CC admission, the LqSOFA outperformed the qSOFA, with a net reclassification index of 10.4% (95% CI, 1.0% to 19.9%). CONCLUSIONS: In this large study, we demonstrate improved performance of the LqSOFA over qSOFA in identifying febrile children at risk for CC admission and sepsis-related mortality. Further validation is required in other settings.


Assuntos
Cuidados Críticos/estatística & dados numéricos , Febre/etiologia , Escores de Disfunção Orgânica , Admissão do Paciente/estatística & dados numéricos , Sepse/diagnóstico , Adolescente , Proteína C-Reativa/análise , Criança , Intervalos de Confiança , Feminino , Humanos , Ácido Láctico/análise , Masculino , Curva ROC , Sepse/complicações , Sepse/mortalidade
9.
Medicine (Baltimore) ; 99(36): e22075, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32899077

RESUMO

Red blood cell distribution width (RDW) is a component of routine complete blood count, which reflects variability in the size of circulating erythrocytes. Recently, there have been many reports about RDW as a strong prognostic marker in various disease conditions in the adult population. However, only a few studies have been performed in children. This study aimed to investigate the association between RDW and pediatric intensive care unit (PICU) mortality in critically ill children. This study includes 960 patients admitted to the PICU from November 2012 to May 2018. We evaluated the associations between RDW and clinical parameters including PICU mortality outcomes. The median age of the study population was 15.5 (interquartile range, 4.8-54.5) months. The mean RDW was 15.6% ±â€Š3.3%. The overall PICU mortality was 8.8%. As we categorized patients into 3 groups with respect to RDW values (Group 1: ≤14.5%; Group 2: 14.5%-16.5%; and Group 3: >16.5%) and compared clinical parameters, the higher RDW groups (Groups 2 and 3) showed more use of vasoactive-inotropic drugs, mechanical ventilator support, higher severity scores, including pediatric risk of mortality III, pediatric sequential organ failure assessment, pediatric logistic organ dysfunction-2 (PELOD-2), and pediatric multiple organ dysfunction syndrome scores, and higher PICU mortality than the lower RDW group (Group 1) (P < .05). Based on multivariate logistic regression analysis adjusted for age and sex, higher RDW value (≥14.5%) was an independent risk factor of PICU mortality. Moreover, adding RDW improved the performance of the PELOD-2 score in predicting PICU mortality (category-free net reclassification index 0.357, 95% confidence interval 0.153-0.562, P = .001). In conclusion, higher RDW value was significantly associated with worse clinical parameters including PICU mortality. RDW was an independent risk factor of PICU mortality and the addition of RDW significantly improved the performance of PELOD-2 score in predicting PICU mortality. Thus, RDW could be a promising prognostic factor with advantages of simple and easy measurement in critically ill pediatric patients.


Assuntos
Estado Terminal/mortalidade , Mortalidade Hospitalar/tendências , Unidades de Terapia Intensiva Pediátrica/estatística & dados numéricos , Fatores Etários , Biomarcadores , Pré-Escolar , Índices de Eritrócitos , Feminino , Humanos , Lactente , Masculino , Insuficiência de Múltiplos Órgãos/mortalidade , Escores de Disfunção Orgânica , Prognóstico , Estudos Prospectivos , Curva ROC , República da Coreia/epidemiologia , Fatores de Risco , Índice de Gravidade de Doença , Fatores Sexuais
12.
Respiration ; 99(8): 649-657, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32841948

RESUMO

BACKGROUND: A new virus broke out in Wuhan, Hubei, China, that was later named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The clinical characteristics of severe pneumonia caused by SARS-CoV-2 are still not clear. OBJECTIVES: The aim of this study was to explore the clinical characteristics and risk factors of severe pneumonia caused by the SARS-CoV-2 in Wuhan, China. METHODS: The study included patients hospitalized at the Central Hospital of Wuhan who were diagnosed with COVID-19. Clinical features, chronic comorbidities, demographic data, laboratory examinations, and chest computed tomography (CT) scans were reviewed through electronic medical records. SPSS was used for data analysis to explore the clinical characteristics and risk factors of patients with severe pneumonia caused by SARS-CoV-2. RESULTS: A total of 110 patients diagnosed with COVID-19 were included in the study, including 38 with severe pneumonia and 72 with nonsevere pneumonia. Statistical analysis showed that advanced age, increased D-Dimer, and decreased lymphocytes were characteristics of the patients with severe pneumonia. Moreover, in the early stage of the disease, chest CT scans of patients with severe pneumonia showed that the illness can progress rapidly. CONCLUSIONS: Advanced age, decreased lymphocytes, and D-Dimer elevation are important characteristics of patients with severe COVID-19. Clinicians should focus on these characteristics to identify high-risk patients at an early stage.


Assuntos
Infecções por Coronavirus/sangue , Produtos de Degradação da Fibrina e do Fibrinogênio/metabolismo , Pulmão/diagnóstico por imagem , Contagem de Linfócitos , Pneumonia Viral/sangue , APACHE , Adulto , Fatores Etários , Betacoronavirus , Proteína C-Reativa/metabolismo , China/epidemiologia , Comorbidade , Infecções por Coronavirus/diagnóstico por imagem , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/fisiopatologia , Tosse/fisiopatologia , Progressão da Doença , Dispneia/fisiopatologia , Fadiga/fisiopatologia , Feminino , Febre/fisiopatologia , Humanos , Hipertensão/epidemiologia , Masculino , Pessoa de Meia-Idade , Peptídeo Natriurético Encefálico/sangue , Escores de Disfunção Orgânica , Pandemias , Pneumonia Viral/diagnóstico por imagem , Pneumonia Viral/epidemiologia , Pneumonia Viral/fisiopatologia , Pró-Calcitonina/sangue , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Síndrome do Desconforto Respiratório do Adulto/sangue , Síndrome do Desconforto Respiratório do Adulto/diagnóstico por imagem , Síndrome do Desconforto Respiratório do Adulto/epidemiologia , Medição de Risco , Albumina Sérica/metabolismo , Índice de Gravidade de Doença , Fatores Sexuais , Tomografia Computadorizada por Raios X
13.
BMC Infect Dis ; 20(1): 595, 2020 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-32787952

RESUMO

BACKGROUND: Severe fever with thrombocytopenia syndrome (SFTS) is a severe systemic virus infectious disease usually having multi-organ dysfunction which resembles sepsis. METHODS: Data of 321 patients with laboratory-confirmed SFTS from May 2013 to July 2017 were retrospectively analyzed. Demographic and clinical characteristics, calculated quick sequential organ failure assessment (qSOFA) score and systemic inflammatory response syndrome (SIRS) criteria for survivors and nonsurvivors were compared. Independent risk factors associated with in-hospital mortality were obtained using multivariable logistic regression analysis. Risk score models containing different risk factors for mortality in stratified patients were established whose predictive values were evaluated using the area under ROC curve (AUC). RESULTS: Of 321 patients, 87 died (27.1%). Age (p < 0.001) and percentage numbers of patients with qSOFA≥2 and SIRS≥2 (p < 0.0001) were profoundly greater in nonsurvivors than in survivors. Age, qSOFA score, SIRS score and aspartate aminotransferase (AST) were independent risk factors for mortality for all patients. qSOFA score was the only common risk factor in all patients, those age ≥ 60 years and those enrolled in the intensive care unit (ICU). A risk score model containing all these risk factors (Model1) has high predictive value for in-hospital mortality in these three groups with AUCs (95% CI): 0.919 (0.883-0.946), 0.929 (0.862-0.944) and 0.815 (0.710-0.894), respectively. A model only including age and qSOFA also has high predictive value for mortality in these groups with AUCs (95% CI): 0.872 (0.830-0.906), 0.885(0.801-0.900) and 0.865 (0.767-0.932), respectively. CONCLUSIONS: Risk models containing qSOFA have high predictive validity for SFTS mortality.


Assuntos
Escores de Disfunção Orgânica , Febre por Flebótomos/complicações , Febre por Flebótomos/mortalidade , Phlebovirus/genética , Trombocitopenia/complicações , Trombocitopenia/mortalidade , Fatores Etários , Idoso , Área Sob a Curva , Aspartato Aminotransferases/sangue , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Febre por Flebótomos/sangue , Prognóstico , Estudos Retrospectivos , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Fatores de Risco , Sepse/mortalidade , Síndrome
14.
JAMA ; 324(7): 642-650, 2020 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-32809003

RESUMO

Importance: The combination of ascorbic acid, corticosteroids, and thiamine has been identified as a potential therapy for septic shock. Objective: To determine whether the combination of ascorbic acid, corticosteroids, and thiamine attenuates organ injury in patients with septic shock. Design, Setting, and Participants: Randomized, blinded, multicenter clinical trial of ascorbic acid, corticosteroids, and thiamine vs placebo for adult patients with septic shock. Two hundred five patients were enrolled between February 9, 2018, and October 27, 2019, at 14 centers in the United States. Follow-up continued until November 26, 2019. Interventions: Patients were randomly assigned to receive parenteral ascorbic acid (1500 mg), hydrocortisone (50 mg), and thiamine (100 mg) every 6 hours for 4 days (n = 103) or placebo in matching volumes at the same time points (n = 102). Main Outcomes and Measures: The primary outcome was change in the Sequential Organ Failure Assessment (SOFA) score (range, 0-24; 0 = best) between enrollment and 72 hours. Key secondary outcomes included kidney failure and 30-day mortality. Patients who received at least 1 dose of study drug were included in analyses. Results: Among 205 randomized patients (mean age, 68 [SD, 15] years; 90 [44%] women), 200 (98%) received at least 1 dose of study drug, completed the trial, and were included in the analyses (101 with intervention and 99 with placebo group). Overall, there was no statistically significant interaction between time and treatment group with regard to SOFA score over the 72 hours after enrollment (mean SOFA score change from 9.1 to 4.4 [-4.7] points with intervention vs 9.2 to 5.1 [-4.1] points with placebo; adjusted mean difference, -0.8; 95% CI, -1.7 to 0.2; P = .12 for interaction). There was no statistically significant difference in the incidence of kidney failure (31.7% with intervention vs 27.3% with placebo; adjusted risk difference, 0.03; 95% CI, -0.1 to 0.2; P = .58) or in 30-day mortality (34.7% vs 29.3%, respectively; hazard ratio, 1.3; 95% CI, 0.8-2.2; P = .26). The most common serious adverse events were hyperglycemia (12 patients with intervention and 7 patients with placebo), hypernatremia (11 and 7 patients, respectively), and new hospital-acquired infection (13 and 12 patients, respectively). Conclusions and Relevance: In patients with septic shock, the combination of ascorbic acid, corticosteroids, and thiamine, compared with placebo, did not result in a statistically significant reduction in SOFA score during the first 72 hours after enrollment. These data do not support routine use of this combination therapy for patients with septic shock. Trial Registration: ClinicalTrials.gov Identifier: NCT03389555.


Assuntos
Corticosteroides/uso terapêutico , Ácido Ascórbico/uso terapêutico , Insuficiência de Múltiplos Órgãos/prevenção & controle , Choque Séptico/tratamento farmacológico , Tiamina/uso terapêutico , Corticosteroides/efeitos adversos , Adulto , Idoso , Ácido Ascórbico/efeitos adversos , Infecção Hospitalar , Quimioterapia Combinada , Feminino , Humanos , Hiperglicemia/induzido quimicamente , Hipernatremia/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Insuficiência de Múltiplos Órgãos/etiologia , Escores de Disfunção Orgânica , Modelos de Riscos Proporcionais , Choque Séptico/complicações , Tiamina/efeitos adversos , Falha de Tratamento
15.
Medicine (Baltimore) ; 99(34): e21893, 2020 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-32846851

RESUMO

We examined the blood concentrations of neutrophil gelatinase-associated lipocalin (NGAL) and citrullinated alpha enolase peptide-1 (CEP-1) antibody in sepsis patients to evaluate their potential diagnostic, classified and prognostic utility together with C-reactive protein (CRP), procalcitonin (PCT), interleukin-6 (IL-6).Sixty-nine patients admitted at the emergency department with sepsis were studied, on admission, their demographic and clinical information were recorded. Blood levels of CRP, PCT, IL-6, NGAL, and CEP-1 antibody were measured. Relationships between sequential [sepsis-related] organ failure assessment score and blood biomarkers, between acute physiology and chronic health evaluation II score and blood biomarkers were investigated. Additionally, the mutual correlation among CRP, PCT, IL-6, NGAL, and CEP-1 antibody were investigated. Diagnostic and predictive values for clinical outcomes for biomarkers were assessed by receiver operator characteristic curve.Sixty-nine participants (38 sepsis, 31 septic shock) were compared with 40 healthy controls. The levels of CRP, PCT, IL-6, and NGAL were significantly higher in sepsis patients ([59.49 ± 48.88]; 0.71, [0.13-11.72]; 60.46, [33.26-201.20]; 265.61, [185.79-500.96], respectively) compared with healthy controls ([2.05 ± 1.85]; 0.02, [0.02-0.03]; 12.08, [7.22-16.84]; 19.73, [7.66-34.39], respectively) (P < .001). CRP, PCT, IL-6, and NGAL had better discriminatory performance with an area under the receiver operator characteristic curve (AUC) of (0.98; 0.98; 0.90; 0.97, respectively), 95% confidence interval (CI) = ([0.95; 1.00]; [0.96; 1.00]; [0.84; 0.96]; [0.94; 1.00], respectively) (P < .001), with a cut off value of (8.02 mg/L [Se = 88.40%, Sp = 100.00%]; 0.06 ng/mL [Se = 94.20%, Sp = 75.00%]; 30.63 pg/mL [Se = 78.30%, Sp = 95.00%]; 95.72 ng/mL [Se = 99.00%, Sp = 92.00%], respectively). Between the sepsis group and septic shock group, PCT and NGAL were significantly higher in septic shock group (2.44, [0.49-20.36]; 294.65 [203.34-1262.47], respectively) compared with sepsis group (0.41, [0.11-2.63]; 219.94, [146.38-385.24], respectively) (P < .05). Between survivors group and nonsurvivors group, PCT was obviously elevated in nonsurvivors group (2.47, [0.70-12.49]) compare with survivors group (0.41, [0.11-8.16]) (P < .05), with an AUC of 0.69, 95% CI = (0.57; 0.81) (P < .05), while CEP-1 antibody was decreased in nonsurvivors group (14.03, [4.94-17.17]) contrast to survivors group (18.78, [8.08-39.72]) (P < .05), with an AUC of 0.67, 95% CI = (0.54; 0.80) (P < .05). Additionally, CEP-1 antibody demonstrated a negative correlation with either sequential [sepsis-related] organ failure assessment score (r = -0.31, P < .05) or PCT (r = -0.27, P < .05).As CRP, PCT, and IL-6, NGAL was valuable in sepsis diagnosis. With a classificatory value, PCT and NGAL correlated with the degree severity of sepsis. PCT and CEP-1 antibody were meaningful in sepsis prognosis. CEP-1 antibody may be a protective factor for sepsis.


Assuntos
Anticorpos/sangue , Lipocalina-2/sangue , Sepse/sangue , Sepse/diagnóstico , Choque Séptico/diagnóstico , Idoso , Idoso de 80 Anos ou mais , Anticorpos Anti-Proteína Citrulinada/sangue , Biomarcadores/sangue , Proteína C-Reativa/análise , Estudos de Casos e Controles , Diagnóstico Diferencial , Serviço Hospitalar de Emergência , Feminino , Humanos , Interleucina-6/sangue , Masculino , Pessoa de Meia-Idade , Escores de Disfunção Orgânica , Fosfopiruvato Hidratase/metabolismo , Valor Preditivo dos Testes , Pró-Calcitonina/sangue , Prognóstico , Estudos Prospectivos , Sepse/classificação , Sepse/mortalidade , Choque Séptico/sangue
16.
Trials ; 21(1): 738, 2020 Aug 24.
Artigo em Inglês | MEDLINE | ID: mdl-32831151

RESUMO

OBJECTIVES: This study aims to determine the protection provided by Shenfu injection (a traditional Chinese medicine) against development of organ dysfunction in critically ill patients with coronavirus disease 2019 (COVID-19). TRIAL DESIGN: This study is a multicenter, randomized, controlled, open-label, two-arm ratio 1:1, parallel group clinical trial. PARTICIPANTS: The patients, who are aged from 18 to 75 years old, with a confirmed or suspected diagnosis of severe or critical COVID-19, will be consecutively recruited in the study, according to the guideline on diagnosis and treatment of COVID-19 (the 7th version) issued by National Health Commission of the People's Republic of China. Exclusion criteria include pregnant and breastfeeding women, atopy or allergies to Shenfu Injection (SFI), severe underlying disease (malignant tumor with multiple metastases, uncontrolled hemopathy, cachexia, severe malnutrition, HIV), active bleeding, obstructive pneumonia caused by lung tumor, severe pulmonary interstitial fibrosis, alveolar proteinosis and allergic alveolitis, continuous use of immunosuppressive drugs in last 6 months, organ transplantation, expected death within 48 hours, the patients considered unsuitable for this study by researchers. The study is conducted in 11 ICUs of designated hospitals for COVID-19, located in 5 cities of China. INTERVENTION AND COMPARATOR: The enrolled patients will randomly receive 100 ml SFI (study group) or identical volume of saline (control group) twice a day for seven consecutive days. Patients in the both groups will be given usual care and the necessary supportive therapies as recommended by the latest edition of the management guidelines for COVID-19 (the 7th version so far). MAIN OUTCOMES: The primary endpoint is a composite of newly developed or exacerbated organ dysfunction. This is defined as an increase in the sequential organ failure assessment (SOFA) score of two or more, indicating sepsis and involvement of at least one organ. The SOFA score will be measured for the 14 days after enrolment from the baseline (the score at randomization). The secondary endpoints are shown below: • SOFA score in total • Pneumonia severity index score • Dosage of vasoactive drugs • Ventilation free days within 28 days • Length of stay in intensive care unit • Total hospital costs to treat the patient • 28-day mortality • The incidence of adverse drug events related to SFI RANDOMISATION: The block randomization codes were generated by SAS V.9.1 for allocation of participants in this study. The ratio of random distribution is 1:1. The sealed envelope method is used for allocation concealment. BLINDING (MASKING): The patients and statistical personnel analyzing study data are both blinded. The blinding of group assignment is not adopted for the medical staff. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): This study is expected to recruit 300 patients with COVID-19, (150 in each group). TRIAL STATUS: Protocol version 2.0, February 15, 2020. Patient recruitment started on February 25, and will end on August 31, 2020. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2000030043. Registered February 21, 2020, http://www.chictr.org.cn/showprojen.aspx?proj=49866 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
Infecções por Coronavirus/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Escores de Disfunção Orgânica , Pneumonia Viral/tratamento farmacológico , Betacoronavirus , China , Infecções por Coronavirus/fisiopatologia , Estado Terminal , Humanos , Pandemias , Pneumonia Viral/fisiopatologia
17.
Trials ; 21(1): 743, 2020 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-32843098

RESUMO

OBJECTIVES: The aim of this study is to explore the effectiveness and safety of high dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to SARS-Cov-2 pneumonia. TRIAL DESIGN: Multicentre, randomized clinical trial, controlled, open label, parallel group, to evaluate the effectiveness and safety of high dose dexamethasone in adult patients with confirmed COVID-19, with Acute Respiratory Distress Syndrome. PARTICIPANTS: We will include patients with SARS-Cov-2 pneumonia who develop acute respiratory distress syndrome, in several intensive care units (ICU) in Buenos Aires, Argentina (CEMIC, Clinica Bazterrica, Sanatorio Sagrado Corazon) Inclusion criteria: Men and women, age ≥ 18 years old. Confirmed diagnosis of SARS-CoV-2 infection, by RT-PCR. Diagnosis of Acute Respiratory Distress Syndrome (hypoxemic respiratory failure not explained by cardiac disease + PaO2/FiO2 ratio < 300 with a Positive End-Expiratory Pressure ≥ 5 cm H2O + bilateral pulmonary infiltrates) Length of mechanical ventilation of at least 72 hours Informed consent (next of kin / legal guardian) Exclusion criteria: Pregnant or breast-feeding women. Terminal disease (advanced cancer; under palliative care; cardiovascular, respiratory, or renal disease with a life expectancy less ≤ 1 year). Therapeutic limitation (advance directives or do not resuscitate order) Severe immunosuppression (HIV infection, long-term use of immunosuppressive agents, active cancer). Patients under chronic treatment with glucocorticoids for other diseases (≥ 8 mg prednisone, or equivalent) Participation in another randomized clinical trial. INTERVENTION AND COMPARATOR: Eligible patients will be randomized to receive standard ICU patient care (group 1) or standard ICU patient care plus high dose dexamethasone (group 2). Group 1: dexamethasone up to 6 mg/24 hours for up to 10 days + ventilatory, hemodynamic, nutritional, and antimicrobial support according to international guidelines. Group 2: dexamethasone 16 mg/24 hours for 5 days followed by dexamethasone 8 mg/24 hours for 5 days + ventilatory, hemodynamic, nutritional, and antimicrobial support according to international guidelines. MAIN OUTCOME: The main result is ventilator-free days at 28 days (Days without ventilator support in the first 28 days following randomization). Secondary outcomes are 28-days and 90-days mortality, frequency of nosocomial infections in the first 28 days after randomization, Sequential Organ Failure Assessment (SOFA) score variation and prone position in the first 10-days, viral shedding 28-days after randomization, and delirium and muscle weakness at ICU discharge. RANDOMISATION: Treatment will be assigned according to site stratified randomization by permuted random blocks sequence 1:1 generated with a table in R language concealed in a randomization tool in REDCap (Research Electronic Data CAPture) platform. BLINDING (MASKING): This is an open trial, so no masking of treatment assignment will be used. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Assuming a 3 days difference in ventilator-free days between treatment groups, with a mean of 9 days, and a standard deviation of 9 days; the necessary sample size would be 284 subjects (142 per group), with a power of 80% and a two-tailed alpha error of 0.05. TRIAL STATUS: The protocol with code 1264, version 3.0 on date: May 13, 2020 is approved by the local Ethics Committee. The trial is in the recruitment phase. Recruitment began May 22, 2020 and is anticipated to be complete by the end of December 2021. TRIAL REGISTRATION: The trial was registered under the title "Dexamethasone for COVID-19 Related ARDS: a Multicenter, Randomized Clinical Trial" with ClinicalTrials number NCT04395105, https://clinicaltrials.gov/ct2/show/NCT04395105 , registered on 20 May 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
Infecções por Coronavirus/tratamento farmacológico , Dexametasona/administração & dosagem , Glucocorticoides/administração & dosagem , Pneumonia Viral/tratamento farmacológico , Síndrome do Desconforto Respiratório do Adulto/tratamento farmacológico , Argentina , Betacoronavirus , Infecções por Coronavirus/complicações , Infecção Hospitalar/epidemiologia , Delírio/epidemiologia , Humanos , Mortalidade , Escores de Disfunção Orgânica , Pandemias , Posicionamento do Paciente , Pneumonia Viral/complicações , Decúbito Ventral , Respiração Artificial/estatística & dados numéricos , Síndrome do Desconforto Respiratório do Adulto/etiologia , Eliminação de Partículas Virais
18.
Intensive Care Med ; 46(9): 1714-1722, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32780165

RESUMO

PURPOSE: Coronavirus disease 2019 (COVID-19) is creating an unprecedented healthcare crisis. Understanding the determinants of mortality is crucial to optimise intensive care unit (ICU) resource use and to identify targets for improving survival. METHODS: In a multicentre retrospective study, we included 379 COVID-19 patients admitted to four ICUs between 20 February and 24 April 2020 and categorised according to time from disease onset to ICU admission. A Cox proportional-hazards model identified factors associated with 28-day mortality. RESULTS: Median age was 66 years (53-68) and 292 (77%) were men. The main comorbidities included obesity and overweight (67%), hypertension (49.6%) and diabetes (30.1%). Median time from disease onset (i.e., viral symptoms) to ICU admission was 8 (6-11) days (missing for three); 161 (42.5%) patients were admitted within a week of disease onset, 173 (45.6%) between 8 and 14 days, and 42 (11.1%) > 14 days after disease onset; day 28 mortality was 26.4% (22-31) and decreased as time from disease onset to ICU admission increased, from 37 to 21% and 12%, respectively. Patients admitted within the first week had higher SOFA scores, more often had thrombocytopenia or acute kidney injury, had more limited radiographic involvement, and had significantly higher blood IL-6 levels. Age, COPD, immunocompromised status, time from disease onset, troponin concentration, and acute kidney injury were independently associated with mortality. CONCLUSION: The excess mortality in patients admitted within a week of disease onset reflected greater non-respiratory severity. Therapeutic interventions against SARS-CoV-2 might impact different clinical endpoints according to time since disease onset.


Assuntos
Infecções por Coronavirus/mortalidade , Unidades de Terapia Intensiva/estatística & dados numéricos , Pneumonia Viral/mortalidade , Fatores Etários , Betacoronavirus , Comorbidade , Feminino , França/epidemiologia , Humanos , Interleucina-6/sangue , Masculino , Pessoa de Meia-Idade , Escores de Disfunção Orgânica , Pandemias , Modelos de Riscos Proporcionais , Reação em Cadeia da Polimerase em Tempo Real , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Tempo para o Tratamento , Troponina/sangue
19.
Lancet ; 396(10250): 545-552, 2020 08 22.
Artigo em Inglês | MEDLINE | ID: mdl-32828186

RESUMO

BACKGROUND: Patients with sepsis-induced cardiomyopathy with cardiogenic shock have a high mortality. This study assessed venoarterial extracorporeal membrane oxygenation (VA-ECMO) support for sepsis-induced cardiogenic shock refractory to conventional treatments. METHODS: In this retrospective, multicentre, international cohort study, we compared outcomes of 82 patients (aged ≥18 years) with septic shock who received VA-ECMO at five academic ECMO centres, with 130 controls (not receiving ECMO) obtained from three large databases of septic shock. All patients had severe myocardial dysfunction (cardiac index 3 L/min per m2 or less or left ventricular ejection fraction [LVEF] 35% or less) and severe haemodynamic compromise (inotrope score at least 75 µg/kg per min or lactic acidaemia at least 4 mmol/L) at time of inclusion. The primary endpoint was survival at 90 days. A propensity score-weighted analysis was done to control for confounders. FINDINGS: At baseline, patients treated with VA-ECMO had more severe myocardial dysfunction (mean cardiac index 1·5 L/min per m2vs 2·2 L/min per m2, LVEF 17% vs 27%), more severe haemodynamic impairment (inotrope score 279 µg/kg per min vs 145 µg/kg per min, lactataemia 8·9 mmol/L vs 6·5 mmol/L), and more severe organ failure (Sequential Organ Failure Assessment score 17 vs 13) than did controls, with p<0·0001 for each comparison. Survival at 90 days for patients treated with VA-ECMO was significantly higher than for controls (60% vs 25%, risk ratio [RR] for mortality 0·54, 95% CI [0·40-0·70]; p<0·0001). After propensity score weighting, ECMO remained associated with improved survival (51% vs 14%, adjusted RR for mortality 0·57, 95% CI [0·35-0·93]; p=0·0029). Lactate and catecholamine clearance were also significantly enhanced in patients treated with ECMO. Among the 49 survivors treated with ECMO, 32 who had been treated at the largest centre reported satisfactory Short Form-36 evaluated health-related quality of life at 1-year follow-up. INTERPRETATION: Patients with severe sepsis-induced cardiogenic shock treated with VA-ECMO had a large and significant improvement in survival compared with controls not receiving ECMO. However, despite the careful propensity-weighted analysis, we cannot rule out unmeasured confounders. FUNDING: None.


Assuntos
Oxigenação por Membrana Extracorpórea/métodos , Choque Cardiogênico/terapia , Choque Séptico/complicações , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Bases de Dados Factuais , Oxigenação por Membrana Extracorpórea/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Escores de Disfunção Orgânica , Qualidade de Vida , Estudos Retrospectivos , Choque Cardiogênico/etiologia , Choque Cardiogênico/mortalidade , Resultado do Tratamento
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