Liberal Versus Restrictive Use of Dobutamine in Cardiac Surgery

Condition(s) targeted: Cardiac Output, Low; Coronary Disease

Intervention: Liberal dobutamine protocol (Drug); Restrictive dobutamine protocol (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University of Sao Paulo

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.

Official title: Liberal Versus Restrictive Dobutamine in Cardiac Surgery (DOBUTACS): a Prospective Randomized Non-inferiority Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

Mortality rate

Acute myocardial infarction incidence

Stroke incidence

Low cardiac output syndrome

Cardiogenic shock

Cardiac arrhythmias

ICU and hospital length of stay

Days free of mechanical ventilation

Severe sepsis and septic shock

SOFA score within 72 hours

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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:

- Previous ventricular dysfunction (ejection fraction lower than 50%)

- Sustained supraventricular or ventricular arrhythmias;

- Cardiogenic shock or need for inotropes before surgery;

- Immediate need of ventricular assist device or intraaortic balloon after CPB;

- Combined procedure;

- Pregnancy;

- Participation in another study.

Heart Institute, Sao Paulo, SP 05403000, Brazil

Starting date: February 2015
Last updated: February 6, 2015