Liberal Versus Restrictive Use of Dobutamine in Cardiac Surgery

NCT ID: NCT02361801

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Liberal dobutamine group

All patients will receive dobutamine at the cardiopulmonary bypass weaning

Group Type: ACTIVE_COMPARATOR

Liberal dobutamine protocol

Intervention Type: DRUG

All patients will receive dobutamine at the cardiopulmonary bypass weaning.

Restrictive dobutamine group

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

Group Type: ACTIVE_COMPARATOR

Restrictive dobutamine protocol

Intervention Type: 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.

Interventions

Liberal dobutamine protocol

All patients will receive dobutamine at the cardiopulmonary bypass weaning.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ludhmila Abrahão Hajjar MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Heart Institute

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33496877 (View on PubMed)

Other Identifiers

DOBUTACS

Identifier Type: -

Identifier Source: org_study_id