Vasoplegia is an important determinant for adverse postoperative outcome and is observerd in 5% to 54% of patients undergoing cardiac surgery using cardiopulmonary bypass (CPB). Postoperative vasoplegia is defined as a state with low systemic vascular resistance despite a normal or high cardiac output, and the need for vasopressor therapy. Steroids attenuate the inflammatory response to cardiopulmonary bypass,but their effect on clinical outcomes is uncertain. This is a double-blinded, randomized, clinical trial designed to determine the efficacy of low dose corticosteroid infusion in vasopressor free-days in vasoplegia after cardiac surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Steroid group will receive 200 mg of hydrocortisone diluted in 120 mL of saline at an infusion rate of 5mL/hr for 3 days or shock reversal
Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal
Incor - Heart Institute - University of Sao Paulo
São Paulo, Brazil
Vasopressors-free days
Days free of vasopressors up to day 30
Time frame: 30 days
30 days mortallity
The number of deaths within 30 days of surgery
Time frame: 30 days
ICU length of stay
Duration in days from the date of the ICU admission to the date of ICU discharge
Time frame: 30 days
Infection complication
Rate of new infection or septic shock within 30 days after randomization
Time frame: 30 days
Acute myocardial infarction
We will compare the incidence of acute myocardial infarction between groups within 30 days after randomization
Time frame: 30 days
Atrial fibrillation
We will compare the incidence of atrial fibrillation between groups within 30 days after randomization
Time frame: 30 days
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