Inotropic agents are usually administered in the postoperative period after cardiac surgery. In most cases, dobutamine is administered routinely, for the probable occurrence of myocardial dysfunction after cardiopulmonary bypass or a low cardiac output with minimal evidence of altered tissue perfusion. Recent data show that inotropic agents are used in 35-52% of cardiac surgeries in the perioperative period. However, the use of inotropic agents may be associated with adverse events, including myocardial ischemia, by elevation in myocardial oxygen consumption and the imbalance between supply and consumption, and tachyarrhythmias (atrial fibrillation, sinus tachycardia, ventricular tachyarrhythmias), primarily due to the β1-adrenergic effect. This study is a non-inferiority clinical randomized study aiming to compare the use of dobutamine in a liberal strategy (in all patients at the time of withdrawal of CPB) with a restrictive strategy (based on clinical and hemodynamic evidence of low cardiac output syndrome associated with altered tissue perfusion). Our primary hypothesis is that the restrictive use of dobutamine is as safe and effective as the liberal one.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
All patients will receive dobutamine at the cardiopulmonary bypass weaning.
Patients will receive dobutamine during the first 8 hours after cardiopulmonary bypass weaning only if they have a cardiac index of ≤ 2.5L/min/m2 and at least one sign of tissue hypoperfusion: ScvO2 ≤ 70% and / or urine output \< 2 mL/Kg/h despite adequate fluid replacement.
Heart Institute
São Paulo, São Paulo, Brazil
Combined endpoint of arrhythmias (ventricular and supraventricular), acute myocardial infarction, stroke or transient ischemic attack, low-output syndrome, cardiogenic shock and death from all causes within 30 days after cardiac surgery
Time frame: 30 days
Mortality rate
We will compare the mortality rate between groups within 30 days after randomization
Time frame: 30 days
Acute myocardial infarction incidence
We will compare the incidence of acute myocardial infarction between groups within 30 days after randomization
Time frame: 30 days
Stroke incidence
We will compare the incidence of stroke between groups within 30 days after randomization
Time frame: 30 days
Low cardiac output syndrome
We will compare the incidence of low cardiac output syndrome between groups within 30 days after randomization
Time frame: 30 days
Cardiogenic shock
We will compare the incidence of cardiogenic shock between groups within 30 days after randomization
Time frame: 30 days
Cardiac arrhythmias
We will compare the incidence of ventricular and supraventricular arrhythmias between groups within 30 days after randomization
Time frame: 30 days
ICU and hospital length of stay
Time frame: 30 days
Days free of mechanical ventilation
We will compare the number of days free of mechanical ventilation between groups within 30 days after randomization
Time frame: 30 days
Severe sepsis and septic shock
We will compare the incidence of severe sepsis and septic shock between groups within 30 days after randomization
Time frame: 30 days
SOFA score within 72 hours
We will compare the SOFA score between groups 72 hours after randomization
Time frame: 72 hours
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