Liberal Versus Restrictive Use of Dobutamine in Cardiac Surgery

Phase 3

Completed

Interventions: Drug: Liberal dobutamine protocol
Drug: Restrictive dobutamine protocol

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Patients undergoing cardiac surgery of coronary artery bypass graft (CABG) with cardiopulmonary bypass;
Age equal or greater than 18 years;
Written informed consent.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Liberal dobutamine group	Liberal dobutamine protocol	All patients will receive dobutamine at the cardiopulmonary bypass weaning
Restrictive dobutamine group	Restrictive dobutamine protocol	Patients will only receive dobutamine if they present clinical signs of cardiogenic shock

Primary Outcome Measures

Name	Time	Method
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	30 days

Secondary Outcome Measures

Name	Time	Method
ICU and hospital length of stay	30 days
Mortality rate	30 days	We will compare the mortality rate between groups within 30 days after randomization
Acute myocardial infarction incidence	30 days	We will compare the incidence of acute myocardial infarction between groups within 30 days after randomization
Stroke incidence	30 days	We will compare the incidence of stroke between groups within 30 days after randomization
Cardiogenic shock	30 days	We will compare the incidence of cardiogenic shock between groups within 30 days after randomization
Low cardiac output syndrome	30 days	We will compare the incidence of low cardiac output syndrome between groups within 30 days after randomization
Cardiac arrhythmias	30 days	We will compare the incidence of ventricular and supraventricular arrhythmias between groups within 30 days after randomization
Days free of mechanical ventilation	30 days	We will compare the number of days free of mechanical ventilation between groups within 30 days after randomization
Severe sepsis and septic shock	30 days	We will compare the incidence of severe sepsis and septic shock between groups within 30 days after randomization
SOFA score within 72 hours	72 hours	We will compare the SOFA score between groups 72 hours after randomization

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