Liberal Versus Restrictive Use of Dobutamine in Cardiac Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 28 March 2022
• Main ID: NCT02361801
• Date of registration: 02/02/2015
• Prospective Registration: No
• Primary sponsor: University of Sao Paulo
• Public title: Liberal Versus Restrictive Use of Dobutamine in Cardiac Surgery DOBUTACS
• Scientific title: Liberal Versus Restrictive Dobutamine in Cardiac Surgery (DOBUTACS): a Prospective Randomized Non-inferiority Clinical Trial
• Date of first enrolment: February 2015
• Target sample size: 160
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02361801
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Brazil

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cardiac Output, Low

Coronary Disease

Intervention(s)

Drug: Liberal dobutamine protocol

Drug: Restrictive dobutamine protocol

Primary Outcome(s)

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]

Secondary Outcome(s)

Stroke incidence [Time Frame: 30 days]

Low cardiac output syndrome [Time Frame: 30 days]

SOFA score within 72 hours [Time Frame: 72 hours]

Acute myocardial infarction incidence [Time Frame: 30 days]

Cardiogenic shock [Time Frame: 30 days]

Days free of mechanical ventilation [Time Frame: 30 days]

Severe sepsis and septic shock [Time Frame: 30 days]

Cardiac arrhythmias [Time Frame: 30 days]

ICU and hospital length of stay [Time Frame: 30 days]

Mortality rate [Time Frame: 30 days]

Secondary ID(s)

DOBUTACS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors