Liberal Versus Restrictive Use of Dobutamine in Cardiac Surgery

NCT02361801 | Completed Phase 3 DMC

• 1 other identifier: DOBUTACS
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Output, Low; Coronary Disease

Keywords

cardiac surgery; dobutamine

Outcome Measures

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

  30 days

Secondary Outcomes (10)

• Mortality rate

  30 days

• Acute myocardial infarction incidence

  30 days

• Stroke incidence

  30 days

• Low cardiac output syndrome

  30 days

• Cardiogenic shock

  30 days

Study Arms (2)

Liberal dobutamine group

ACTIVE COMPARATOR

All patients will receive dobutamine at the cardiopulmonary bypass weaning

Drug: Liberal dobutamine protocol

Restrictive dobutamine group

ACTIVE COMPARATOR

Patients will only receive dobutamine if they present clinical signs of cardiogenic shock

Drug: Restrictive dobutamine protocol

Interventions

Liberal dobutamine protocol DRUG

All patients will receive dobutamine at the cardiopulmonary bypass weaning.

Liberal dobutamine group

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.

Restrictive dobutamine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing cardiac surgery of coronary artery bypass graft (CABG) with cardiopulmonary bypass;
• Age equal or greater than 18 years;
• Written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Heart Institute

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 33496877 DERIVED

MeSH Terms

Conditions

Cardiac Output, Low; Coronary Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 12, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2018
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

BR (1)