Clinical trial NCT02361801: Liberal Versus Restrictive Use of Dobutamine in Cardiac Surgery
Official title: Liberal Versus Restrictive Dobutamine in Cardiac Surgery (DOBUTACS): a Prospective Randomized Non-inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Output, Low
Coronary Disease
Keywords: cardiac surgery
dobutamine
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 30 days
Secondary outcomes:
measure: Mortality rate
timeFrame: 30 days
measure: Acute myocardial infarction incidence
timeFrame: 30 days
measure: Stroke incidence
timeFrame: 30 days
measure: Low cardiac output syndrome
timeFrame: 30 days
measure: Cardiogenic shock
timeFrame: 30 days
measure: Cardiac arrhythmias
timeFrame: 30 days
measure: ICU and hospital length of stay
timeFrame: 30 days
measure: Days free of mechanical ventilation
timeFrame: 30 days
measure: Severe sepsis and septic shock
timeFrame: 30 days
measure: SOFA score within 72 hours
timeFrame: 72 hours
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute
state: SP
Study officials:
References:
citation: Franco RA, de Almeida JP, Landoni G, Scheeren TWL, Galas FRBG, Fukushima JT, Zefferino S, Nardelli P, de Albuquerque Piccioni M, Arita ECTC, Park CHL, Cunha LCC, de Oliveira GQ, Costa IBSDS, Kalil Filho R, Jatene FB, Hajjar LA. Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial. Ann Intensive Care. 2021 Jan 26;11(1):15. doi: 10.1186/s13613-021-00808-6.