Skip to main content
OpenTrials
Completed

NCT Number: NCT02361801

Liberal Versus Restrictive Use of Dobutamine in Cardiac Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Output, Low Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Heart Institute

São Paulo, 05403000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liberal dobutamine protocol

Drug

All patients will receive dobutamine at the cardiopulmonary bypass weaning.

Restrictive dobutamine protocol

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. Mortality rate

    Time frame: 30 days

    We will compare the mortality rate between groups within 30 days after randomization

  2. Acute myocardial infarction incidence

    Time frame: 30 days

    We will compare the incidence of acute myocardial infarction between groups within 30 days after randomization

  3. Stroke incidence

    Time frame: 30 days

    We will compare the incidence of stroke between groups within 30 days after randomization

  4. Low cardiac output syndrome

    Time frame: 30 days

    We will compare the incidence of low cardiac output syndrome between groups within 30 days after randomization

  5. Cardiogenic shock

    Time frame: 30 days

    We will compare the incidence of cardiogenic shock between groups within 30 days after randomization

  6. Cardiac arrhythmias

    Time frame: 30 days

    We will compare the incidence of ventricular and supraventricular arrhythmias between groups within 30 days after randomization

  7. ICU and hospital length of stay

    Time frame: 30 days

  8. Days free of mechanical ventilation

    Time frame: 30 days

    We will compare the number of days free of mechanical ventilation between groups within 30 days after randomization

  9. Severe sepsis and septic shock

    Time frame: 30 days

    We will compare the incidence of severe sepsis and septic shock between groups within 30 days after randomization

  10. SOFA score within 72 hours

    Time frame: 72 hours

    We will compare the SOFA score between groups 72 hours after randomization

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Acronym: DOBUTACS

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Feb 12, 2015
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.