Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial
Lancet
; 386(10000): 1243-1253, 2015.
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1064577
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
BACKGROUND:
Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass.METHODS:
The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (11) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388...
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Coleções:
Bases de dados nacionais
/
Brasil
Contexto em Saúde:
ODS3 - Meta 3.4 Reduzir as mortes prematuras devido doenças não transmissíveis
Problema de saúde:
Doença dos Órgãos dos Sentidos
Base de dados:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Metilprednisolona
/
Circulação Extracorpórea
Tipo de estudo:
Ensaio clínico controlado
Idioma:
Inglês
Revista:
Lancet
Ano de publicação:
2015
Tipo de documento:
Artigo
Instituição/País de afiliação:
All India Institute of Medical Sciences/IN
/
Department of Anesthesiology, West China Hospital, Sichuan University/CN
/
Department of Cardiovascular and Thoracic Surgery, University of Thessaly/GR
/
Department of Outcomes Research, Cleveland Clinic/US
/
Department of Surgery, Southlake Regional Health Centre/CA
/
First Teaching Hospital of Xinjiang Medical University/CN
/
Fundación Cardio InfantilInstituto de Cardiología/CO
/
Instituto Dante Pazzanese de Cardiologia/BR
/
London Health Sciences Centre/CA
/
Population Health Research Institute, Hamilton Health Sciences and McMaster University/CA