Liberal Versus Restrictive Use of Dobutamine in Cardiac Surgery

Coronary Disease Clinical Trial

— DOBUTACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361801
• Other study ID #: DOBUTACS
• Status: Completed
• Phase: Phase 3
• Start date: February 2015
• Est. completion date: June 2018

Study information

• Verified date: March 2022
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2018
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• 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.

Related Conditions & MeSH terms

• Cardiac Output, Low
• Coronary Disease

Intervention

Drug:
• Liberal dobutamine protocol
All patients will receive dobutamine at the cardiopulmonary bypass weaning.
• Restrictive dobutamine protocol
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.

Locations

Country	Name	City	State
Brazil	Heart Institute	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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