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3.
BMC Emerg Med ; 22(1): 45, 2022 03 19.
Artigo em Inglês | MEDLINE | ID: mdl-35305569

RESUMO

BACKGROUND: Recent studies have shown that reducing pre-hospital time could improve the outcomes of trauma victims. Due to the importance of pre-hospital time management, this study aims to determine the effects of the Pre-hospital Trauma Life Support (PHTLS) training program on the on-scene time interval reduction. METHODS: The PHTLS training program was implemented based on global standards for pre-hospital emergency technicians. The research tool was a questionnaire designed by the Ministry of Health and Medical Education in Iran. The mean on-scene time interval was calculated before, after and one month after the intervention in the control (n = 32) and experimental group (n = 32). The data were analyzed using SPSS. RESULTS: The mean on-scene time interval in the target group (one month after intervention) has been significantly lower than that of the control group. Moreover, the mean and standard deviation from the on-scene time interval in the target group has been reduced from 17.6 ± 5.5 (before intervention) to 12 ± 3.8 min (one month after intervention) which was statistically significant. CONCLUSION: The implementation of the PHTLS training program can lead to the reduction of on-scene time interval. Therefore, considering the role of reducing on-scene time intervals on victims' survival, the integration of the PHTLS training programs with pre-hospital emergency medical service systems seems inevitable.


Assuntos
Serviços Médicos de Emergência , Auxiliares de Emergência , Auxiliares de Emergência/educação , Hospitais , Humanos , Irã (Geográfico) , Cuidados para Prolongar a Vida
5.
J Clin Ethics ; 33(1): 50-57, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35302519

RESUMO

In this article, we discuss the case of Michael Johnson, an African-American man who sought treatment for respiratory distress due to COVID-19, but who was adamant that he did not want to be intubated due to his belief that ventilators directly cause death. This case prompted reflection about the ways in which a false belief can create uncertainty and complexity for clinicians who are responsible for evaluating decision-making capacity (DMC). In our analysis, we consider the extent to which Mr. Johnson demonstrated capacity according to each of Appelbaum's criteria.1 Although it was fairly clear that Mr. Johnson lacked DMC on the basis of both understanding and appreciation, we found ourselves reflecting upon the false belief that seemed to motivate his refusal. This led us to further consider the ways in which our current social and political environment can complicate evaluations of patients' preferences and reasons for declining life-sustaining interventions. In particular, we consider the impact of the role of misinformation and systemic racism in preparing the grounds for false beliefs.In this article, we discuss the case of Michael Johnson, an African-American man who sought treatment for respiratory distress due to COVID-19, but who was adamant that he did not want to be intubated due to his belief that ventilators directly cause death. This case prompted reflection about the ways in which a false belief can create uncertainty and complexity for clinicians who are responsible for evaluating decision-making capacity (DMC). In our analysis, we consider the extent to which Mr. Johnson demonstrated capacity according to each of Appelbaum's criteria.1 Although it was fairly clear that Mr. Johnson lacked DMC on the basis of both understanding and appreciation, we found ourselves reflecting upon the false belief that seemed to motivate his refusal. This led us to further consider the ways in which our current social and political environment can complicate evaluations of patients' preferences and reasons for declining life-sustaining interventions. In particular, we consider the impact of the role of misinformation and systemic racism in preparing the grounds for false beliefs.


Assuntos
Tomada de Decisões , Conhecimentos, Atitudes e Prática em Saúde , Competência Mental , Afro-Americanos/psicologia , COVID-19/etnologia , COVID-19/terapia , Conhecimentos, Atitudes e Prática em Saúde/etnologia , Humanos , Cuidados para Prolongar a Vida , Masculino , Recusa do Paciente ao Tratamento/etnologia , Ventiladores Mecânicos
6.
Acta Anaesthesiol Scand ; 66(4): 526-538, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35118641

RESUMO

BACKGROUND: Few studies have examined the factors that predict the limitations of life-sustaining treatment (LST) to patients in intensive care units (ICUs). We aimed to identify variables associated with the decision of withholding of life support (WHLS) at admission, WHLS during ICU stay and the withdrawal of ongoing life support (WDLS). METHODS: This retrospective observational study comprised 17,772 adult ICU patients who were included in the nationwide Finnish ICU Registry in 2016. Factors associated with LST limitations were identified using hierarchical logistic regression. RESULTS: The decision of WHLS at admission was made for 822 (4.6%) patients, WHLS during ICU stay for 949 (5.3%) patients, and WDLS for 669 (3.8%) patients. Factors strongly predicting WHLS at admission included old age (adjusted odds ratio [OR] for patients aged 90 years or older in reference to those younger than 40 years was 95.6; 95% confidence interval [CI], 47.2-193.5), dependence on help for activities of daily living (OR, 3.55; 95% CI, 3.01-4.2), and metastatic cancer (OR, 4.34; 95% CI, 3.16-5.95). A high severity of illness predicted later decisions to limit LST. Diagnoses strongly associated with WHLS at admission were cardiac arrest, hepatic failure and chronic obstructive pulmonary disease. Later decisions were strongly associated with cardiac arrest, hepatic failure, non-traumatic intracranial hemorrhage, head trauma and stroke. CONCLUSION: Early decisions to limit LST were typically associated with old age and chronic poor health whereas later decisions were related to the severity of illness. Limitations are common for certain diagnoses, particularly cardiac arrest and hepatic failure.


Assuntos
Parada Cardíaca , Falência Hepática , Atividades Cotidianas , Adulto , Finlândia/epidemiologia , Humanos , Unidades de Terapia Intensiva , Cuidados para Prolongar a Vida , Estudos Prospectivos , Estudos Retrospectivos , Suspensão de Tratamento
9.
N Engl J Med ; 386(8): 713-723, 2022 02 24.
Artigo em Inglês | MEDLINE | ID: mdl-35021004

RESUMO

BACKGROUND: The increasing incidence of pediatric hospitalizations associated with coronavirus disease 2019 (Covid-19) caused by the B.1.617.2 (delta) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the United States has offered an opportunity to assess the real-world effectiveness of the BNT162b2 messenger RNA vaccine in adolescents between 12 and 18 years of age. METHODS: We used a case-control, test-negative design to assess vaccine effectiveness against Covid-19 resulting in hospitalization, admission to an intensive care unit (ICU), the use of life-supporting interventions (mechanical ventilation, vasopressors, and extracorporeal membrane oxygenation), or death. Between July 1 and October 25, 2021, we screened admission logs for eligible case patients with laboratory-confirmed Covid-19 at 31 hospitals in 23 states. We estimated vaccine effectiveness by comparing the odds of antecedent full vaccination (two doses of BNT162b2) in case patients as compared with two hospital-based control groups: patients who had Covid-19-like symptoms but negative results on testing for SARS-CoV-2 (test-negative) and patients who did not have Covid-19-like symptoms (syndrome-negative). RESULTS: A total of 445 case patients and 777 controls were enrolled. Overall, 17 case patients (4%) and 282 controls (36%) had been fully vaccinated. Of the case patients, 180 (40%) were admitted to the ICU, and 127 (29%) required life support; only 2 patients in the ICU had been fully vaccinated. The overall effectiveness of the BNT162b2 vaccine against hospitalization for Covid-19 was 94% (95% confidence interval [CI], 90 to 96); the effectiveness was 95% (95% CI, 91 to 97) among test-negative controls and 94% (95% CI, 89 to 96) among syndrome-negative controls. The effectiveness was 98% against ICU admission and 98% against Covid-19 resulting in the receipt of life support. All 7 deaths occurred in patients who were unvaccinated. CONCLUSIONS: Among hospitalized adolescent patients, two doses of the BNT162b2 vaccine were highly effective against Covid-19-related hospitalization and ICU admission or the receipt of life support. (Funded by the Centers for Disease Control and Prevention.).


Assuntos
COVID-19/prevenção & controle , Adolescente , COVID-19/mortalidade , COVID-19/terapia , Teste para COVID-19 , Vacinas contra COVID-19 , Estudos de Casos e Controles , Criança , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Imunização Secundária , Unidades de Terapia Intensiva , Cuidados para Prolongar a Vida , Masculino , Gravidade do Paciente , SARS-CoV-2 , Estados Unidos
11.
World Neurosurg ; 157: e179-e187, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34626845

RESUMO

OBJECTIVE: Risk factors for mortality in patients with subdural hematoma (SDH) include poor Glasgow Coma Scale (GCS) score, pupil nonreactivity, and hemodynamic instability on presentation. Little is published regarding prognosticators of SDH in the elderly. This study aims to examine risk factors for hospital mortality and withdrawal of life-sustaining measures in an octogenarian population presenting with SDH. METHODS: A prospectively collected multicenter database of 3279 traumatic brain injury admissions to 45 different U.S. trauma centers between 2017 and 2019 was queried to identify patients aged >79 years old presenting with SDH. Factors collected included baseline demographic data, past medical history, antiplatelet/anticoagulant use, and clinical presentation (GCS, pupil reactivity, injury severity scale [ISS]). Primary outcome data included hospital mortality/discharge to hospice care and withdrawal of life-sustaining measures. Multivariate logistic regression analyses were used to identify factors independently associated with primary outcome variables. RESULTS: A total of 695 patients were isolated for analysis. Of the total cohort, the rate of hospital mortality or discharge to hospice care was 22% (n = 150) and the rate of withdrawal of life-sustaining measures was 10% (n = 66). A multivariate logistic regression model identified GCS <13, pupil nonreactivity, increasing ISS, intraventricular hemorrhage, and neurosurgical intervention as factors independently associated with hospital mortality/hospice. Congestive heart failure (CHF), hypotension, GCS <13, and neurosurgical intervention were independently associated with withdrawal of life-sustaining measures. CONCLUSIONS: Poor GCS, pupil nonreactivity, ISS, and intraventricular hemorrhage are independently associated with hospital mortality or discharge to hospice care in patients >80 years with SDH. Pre-existing CHF may further predict withdrawal of life-sustaining measures.


Assuntos
Hematoma Subdural/mortalidade , Mortalidade Hospitalar/tendências , Cuidados para Prolongar a Vida/tendências , Alta do Paciente/tendências , Suspensão de Tratamento/tendências , Idoso de 80 Anos ou mais , Lesões Encefálicas Traumáticas/diagnóstico , Lesões Encefálicas Traumáticas/mortalidade , Lesões Encefálicas Traumáticas/terapia , Feminino , Escala de Coma de Glasgow/tendências , Hematoma Subdural/diagnóstico , Hematoma Subdural/terapia , Humanos , Masculino , Valor Preditivo dos Testes , Estudos Prospectivos , Estudos Retrospectivos
12.
Eur J Cancer ; 160: 261-272, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34799210

RESUMO

AIM OF THE STUDY: The coronavirus disease 2019 (COVID-19) pandemic significantly impacted cancer care. In this study, clinical patient characteristics related to COVID-19 outcomes and advanced care planning, in terms of non-oncological treatment restrictions (e.g. do-not-resuscitate codes), were studied in patients with cancer and COVID-19. METHODS: The Dutch Oncology COVID-19 Consortium registry was launched in March 2020 in 45 hospitals in the Netherlands, primarily to identify risk factors of a severe COVID-19 outcome in patients with cancer. Here, an updated analysis of the registry was performed, and treatment restrictions (e.g. do-not-intubate codes) were studied in relation to COVID-19 outcomes in patients with cancer. Oncological treatment restrictions were not taken into account. RESULTS: Between 27th March 2020 and 4th February 2021, 1360 patients with cancer and COVID-19 were registered. Follow-up data of 830 patients could be validated for this analysis. Overall, 230 of 830 (27.7%) patients died of COVID-19, and 60% of the remaining 600 patients with resolved COVID-19 were admitted to the hospital. Patients with haematological malignancies or lung cancer had a higher risk of a fatal outcome than other solid tumours. No correlation between anticancer therapies and the risk of a fatal COVID-19 outcome was found. In terms of end-of-life communication, 50% of all patients had restrictions regarding life-prolonging treatment (e.g. do-not-intubate codes). Most identified patients with treatment restrictions had risk factors associated with fatal COVID-19 outcome. CONCLUSION: There was no evidence of a negative impact of anticancer therapies on COVID-19 outcomes. Timely end-of-life communication as part of advanced care planning could save patients from prolonged suffering and decrease burden in intensive care units. Early discussion of treatment restrictions should therefore be part of routine oncological care, especially during the COVID-19 pandemic.


Assuntos
COVID-19/mortalidade , Hospitalização/estatística & dados numéricos , Cuidados para Prolongar a Vida/estatística & dados numéricos , Mortalidade/tendências , Neoplasias/mortalidade , SARS-CoV-2/isolamento & purificação , Suspensão de Tratamento/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , COVID-19/epidemiologia , COVID-19/terapia , COVID-19/virologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/epidemiologia , Neoplasias/terapia , Neoplasias/virologia , Países Baixos/epidemiologia , Prognóstico , Fatores de Risco , Taxa de Sobrevida
13.
J Med Ethics ; 48(1): 50-55, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-32371594

RESUMO

PURPOSE: Scarce evidence exists regarding end-of-life decision (EOLD) in neurocritically ill patients. We investigated the factors associated with EOLD making, including the group and individual characteristics of involved healthcare professionals, in a multiprofessional neurointensive care unit (NICU) setting. MATERIALS AND METHODS: A prospective, observational pilot study was conducted between 2013 and 2014 in a 10-bed NICU. Factors associated with EOLD in long-term neurocritically ill patients were evaluated using an anonymised survey based on a standardised questionnaire. RESULTS: 8 (25%) physicians and 24 (75%) nurses participated in the study by providing their 'treatment decisions' for 14 patients at several time points. EOLD was 'made' 44 (31%) times, while maintenance of life support 98 (69%) times. EOLD patterns were not significantly different between professional groups. The individual characteristics of the professionals (age, gender, religion, personal experience with death of family member and NICU experience) had no significant impact on decisions to forgo or maintain life-sustaining therapy. EOLD was patient-specific (intraclass correlation coefficient: 0.861), with the presence of acute life-threatening disease (OR (95% CI): 18.199 (1.721 to 192.405), p=0.038) and low expected patient quality of life (OR (95% CI): 9.276 (1.131 to 76.099), p=0.016) being significant and independent determinants for withholding or withdrawing life-sustaining treatment. CONCLUSIONS: Our findings suggest that EOLD in NICU relies mainly on patient prognosis and not on the characteristics of the healthcare professionals.


Assuntos
Qualidade de Vida , Assistência Terminal , Tomada de Decisões , Humanos , Cuidados para Prolongar a Vida , Projetos Piloto , Estudos Prospectivos , Suspensão de Tratamento
14.
Crit Care Med ; 50(2): e183-e188, 2022 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-34369429

RESUMO

OBJECTIVES: To describe the unassisted return of spontaneous circulation following withdrawal of life-sustaining treatment in a child. DESIGN: Case report based on clinical observation and medical record review. SETTING: Community Children's Hospital. PATIENT: Two-year old child. INTERVENTIONS: Following hypoxic-ischemic brain injury, the child was taken to the operating room for withdrawal of life-sustaining treatment during controlled donation after circulatory determination of death. MEASUREMENTS AND MAIN RESULTS: In addition to direct observation by experienced pediatric critical care providers, the child was monitored with electrocardiography, pulse oximetry, and invasive blood pressure via femoral arterial catheter in addition to direct observation by experienced pediatric critical care providers. Unassisted return of spontaneous circulation occurred greater than 2 minutes following circulatory arrest and was accompanied by return of respiration. CONCLUSIONS: We provide the first report of unassisted return of spontaneous circulation following withdrawal of life-sustaining treatment in a child. In our case, return of spontaneous circulation occurred in the setting of controlled donation after circulatory determination of death and was accompanied by return of respiration. Return of spontaneous circulation greater than 2 minutes following circulatory arrest in our patient indicates that 2 minutes of observation is insufficient to ensure that cessation of circulation is permanent after withdrawal of life-sustaining treatment in a child.


Assuntos
Cuidados para Prolongar a Vida/métodos , Retorno da Circulação Espontânea/fisiologia , Choque/terapia , Suspensão de Tratamento , Morte Encefálica/fisiopatologia , Pré-Escolar , Humanos , Masculino , Pediatria/métodos , Pediatria/normas , Choque/complicações
15.
Crit Care Med ; 50(4): 576-585, 2022 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-34402458

RESUMO

OBJECTIVES: Differences in decisions to limit life-sustaining therapy are often supported by perceptions that patients receive unnecessary and expensive treatment which provide negligible survival benefit. However, the assumption behind those beliefs-that is, that life-sustaining therapy provides no significant marginal survival benefit-remains unproven. Our objective was to quantify the effects of variations in decisions to withdraw or withhold life-sustaining treatment on 180-day mortality in critically ill patients. DESIGN: Retrospective observational cohort study of a national clinical database. SETTING: Adult ICUs participating in the Intensive Care National Audit and Research Center Case Mix Program in the United Kingdom. PATIENTS: Adult patients admitted to general ICUs between April 1, 2009, and March 31, 2016. MEASUREMENTS AND MAIN RESULTS: During the study period, 795,721 patients were admitted to 247 ICUs across the United Kingdom. A decision to withdraw or withhold life-sustaining treatment was made for 92,327 patients (11.6%). A multilevel model approach was used to estimate ICU-level practice variation. The ICU-level practice variation was then used as an instrument to measure the effects of decision to withdraw or withhold life-sustaining treatment on 180-day mortality. The marginal population was estimated to be 5.9% of the total cohort. A decision to withdraw or withhold life-sustaining treatment was associated with a marginal increase in 180-day mortality of 25.6% (95% CI, 23.2-27.9%). CONCLUSIONS: Decision to withdraw or withhold life-sustaining treatment in critically ill adults in the United Kingdom was associated with increased 180-day mortality in the marginal patients. The increased mortality from a decision to withdraw or withhold life-sustaining treatment in the marginal patient may be informative when establishing patients' preferences and evaluating the cost-effectiveness of intensive treatments.


Assuntos
Estado Terminal , Unidades de Terapia Intensiva , Adulto , Estado Terminal/terapia , Tomada de Decisões , Humanos , Cuidados para Prolongar a Vida , Estudos Retrospectivos , Suspensão de Tratamento
16.
Eur Geriatr Med ; 13(1): 101-107, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34282526

RESUMO

PURPOSE: There are no guidelines or consensus statements on the terms to be used when discussing withholding of treatment for patients in acute geriatric care units and who have not received palliative care. The objective of the present study was to analyze the terms used in medical records to refer to the withholding of treatment for patients who died in an acute geriatric care unit and did not receive palliative care. METHODS: We conducted an ambispective multicentre cohort study based on the DAMAGE study. Data on 53 patients who died in the acute geriatric care unit and who had not received palliative care were extracted from medical records. The verbatims referring to the withholding of treatment were analyzed in terms of keywords and then key concepts, as defined by several reviewers in a consensus-based approach. RESULTS: The mean age of the patients was 86.4 years, 34.1% were male. Terms referring to the withholding of treatment were found for 25 of the 53 patients (47.2%). Most of the decisions on the withholding of treatment were recorded in the week following admission to the acute geriatric care unit. Our analysis of the terms identified 11 key concepts: treatment limitation, no resuscitation, withholding diagnostic procedures, justification of care, ethical considerations, disease progression, uncertainty, the patient's wishes, the family's wishes, patient's comfort, and collegiality. The terms used to describe key concepts varied markedly from one physician to another. CONCLUSION: Decisions about the withholding of treatment are frequently noted in the medical records of patients who die in the acute geriatric care unit without having received palliative care. The broad variety of key concepts and differences in the choice of words highlight the need for standardized terms.


Assuntos
Cuidados Paliativos , Médicos , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Humanos , Cuidados para Prolongar a Vida , Masculino , Suspensão de Tratamento
17.
Saúde Soc ; 31(1): e201078, 2022. tab
Artigo em Português | LILACS | ID: biblio-1352212

RESUMO

Resumo Embora políticas públicas de cuidados prolongados estejam começando a ser implementadas na América Latina, poucos estudos analisam a situação dos países que compõem a região. Este estudo tem por objetivo examinar programas públicos de cuidados prolongados na Costa Rica e estimar a demanda do país por cuidados formais. Os dados foram obtidos por meio de revisão das Contas Nacionais de Saúde, cinco entrevistas com representantes de instituições governamentais, revisão da literatura científica e relatórios oficiais, e análise dos dados extraídos de uma pesquisa nacional de cuidados. Os resultados indicam a existência de programas fragmentados e focados no enfrentamento à pobreza que não foram projetados para atender às necessidades de cuidados prolongados. Estima-se que, atualmente, 13,4% dos idosos da região necessitam de ajuda na execução de atividades básicas da vida diária, e que o trabalho informal de cuidados é intensivo, oferecido principalmente por um membro da família, e não remunerado.


Abstract Latin America is beginning to implement long-term care public policies. But only a few studies look at the situation of the countries in the region. This study aims to examine long-term care public programs in Costa Rica and to estimate the country's demand for formal care. For this purpose, we have revised its National Health Accounts, conducted five interviews with representatives of governmental institutions, reviewed the scientific literature and official reports, and analyzed the data drawn from a national care survey. The results show the existence of fragmented, poverty-focused programs that were not designed for long-term care needs. The estimated percentage of older adults in the region that currently require help to perform activities of daily living is 13.4%. The informal care work is intensive, mostly provided by a family member, and unpaid.


Assuntos
Humanos , Masculino , Feminino , Pobreza , Política Pública , Envelhecimento , Adaptação Psicológica , Estado Funcional , Cuidados para Prolongar a Vida
19.
Rev. colomb. anestesiol ; 49(4): e303, Oct.-Dec. 2021. tab, graf
Artigo em Inglês | LILACS, COLNAL | ID: biblio-1341242

RESUMO

Abstract Life support withdrawal can be a challenging decision, but it should be considered as an option when death is inevitable or recovery to an acceptable quality of life is not possible. The process is beset by obstacles that must be overcome to finally offer patients comfort and a peaceful death. In this article, we offer a series of tools that seek to solve the challenges of palliative extubation, as well as a protocol that could facilitate the decision to withdraw life support, making palliative extubation an alternative to consider instead of artificially prolonging life at the expense of unacceptable human and economic costs.


Resumen La interrupción de la asistencia vital puede ser una decisión complicada, aun cuando se debe considerar como una opción cuando la muerte es inevitable o la recuperación a una calidad de vida aceptable no es posible. A lo largo del proceso se encuentran obstáculos que se deben sortear para finalmente ofrecer a los pacientes una muerte tranquila y confortable. En este artículo ofrecemos una serie de herramientas que buscan solucionar los desafíos de la extubación paliativa y presentamos una guía de extubación que podría facilitar la decisión de retiro del soporte vital, haciendo de la extubación paliativa una alternativa por considerar en lugar de prolongar la vida de manera artificial a expensas de un costo humano y económico inaceptable.


Assuntos
Humanos , Cuidados Paliativos , Direito a Morrer , Extubação , Cuidados para Prolongar a Vida , Qualidade de Vida , Cuidados Críticos , Protocolos/prevenção & controle
20.
JAMA ; 326(18): 1807-1817, 2021 11 09.
Artigo em Inglês | MEDLINE | ID: mdl-34673895

RESUMO

Importance: A daily dose with 6 mg of dexamethasone is recommended for up to 10 days in patients with severe and critical COVID-19, but a higher dose may benefit those with more severe disease. Objective: To assess the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia. Design, Setting, and Participants: A multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation. End of 90-day follow-up was on August 19, 2021. Interventions: Patients were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n = 503) or 6 mg/d of intravenous dexamethasone (n = 497) for up to 10 days. Main Outcomes and Measures: The primary outcome was the number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days and was adjusted for stratification variables. Of the 8 prespecified secondary outcomes, 5 are included in this analysis (the number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality at 28 days and at 90 days, and ≥1 serious adverse reactions at 28 days). Results: Of the 1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and primary outcome data were available for 971 (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group). The median number of days alive without life support was 22.0 days (IQR, 6.0-28.0 days) in the 12 mg of dexamethasone group and 20.5 days (IQR, 4.0-28.0 days) in the 6 mg of dexamethasone group (adjusted mean difference, 1.3 days [95% CI, 0-2.6 days]; P = .07). Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group (adjusted relative risk, 0.86 [99% CI, 0.68-1.08]). Mortality at 90 days was 32.0% in the 12 mg of dexamethasone group vs 37.7% in the 6 mg of dexamethasone group (adjusted relative risk, 0.87 [99% CI, 0.70-1.07]). Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83 [99% CI, 0.54-1.29]). Conclusions and Relevance: Among patients with COVID-19 and severe hypoxemia, 12 mg/d of dexamethasone compared with 6 mg/d of dexamethasone did not result in statistically significantly more days alive without life support at 28 days. However, the trial may have been underpowered to identify a significant difference. Trial Registration: ClinicalTrials.gov Identifier: NCT04509973 and ctri.nic.in Identifier: CTRI/2020/10/028731.


Assuntos
COVID-19/tratamento farmacológico , Dexametasona/administração & dosagem , Glucocorticoides/administração & dosagem , Cuidados para Prolongar a Vida , Idoso , COVID-19/complicações , COVID-19/mortalidade , Dexametasona/efeitos adversos , Relação Dose-Resposta a Droga , Feminino , Glucocorticoides/efeitos adversos , Humanos , Hipóxia/etiologia , Hipóxia/terapia , Masculino , Pessoa de Meia-Idade , Micoses/etiologia , Respiração Artificial , Choque Séptico/etiologia , Método Simples-Cego
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