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...