Recruiting

Inotrope

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT05267886

Conditions

Shock, Cardiogenic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dobutamine

Milrinone

Normal Saline

Study Details

Brief summary:

The investigators are interested in determining if there is a meaningful benefit from the use of medications purported to increase the pumping function of the heart (i.e. inotropes) among critically ill patients admitted to the Cardiac Intensive Care Unit (CICU). To do this, the investigators will conduct a multi-centre, double blind, randomized control trial with patients who are deemed to require these medications by their treating physician to one of the two most commonly used agents in Canada (Milrinone or Dobutamine) or placebo. Each patient will be closely monitored by their healthcare team. The dose of medication will be adjusted according to each patients' clinical status. After 12 hours, the participants will move to open label treatment and any continued use of inotropes will be at the discretion of their treating physician.

Conditions

Shock, Cardiogenic

Study ID

NCT05267886

Start date

Mar 5, 2022

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients ≥ 18 years of age admitted to an intensive care unit
  • SCAI class C or D cardiogenic shock

Exclusion Criteria:

  • Unwilling or unable to obtain informed consent by the participant or substitute decision maker
  • Patients who are currently pregnant or breast-feeding
  • Patients presenting with an out-of-hospital cardiac arrest (OHCA)
  • Administration of milrinone or dobutamine in the 24 hours preceding anticipated randomization
  • Severe obstructive valvular lesions, including aortic stenosis and/or mitral stenosis
  • Dynamic left ventricular outflow tract obstruction

Study Design

Enrollment

346 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Inotrope

Participants randomized to receive the inotrope will be initiated on inotrope therapy at starting doses and titrated according to standard clinical care. During reassessment, the treating physicians will make a decision about adjustment of the inotrope dose (increase, maintain or decrease) based on hemodynamics, end-organ perfusion, vasopressor support and clinical exam. Dobutamine doses will be 2.5, 5.0, 7.5, 10 and >10 ug/kg/min and milrinone doses will be 0.125, 0.250, 0.375, 0.5 and >0.5 ug/kg/min. These dose stages are identical to those used in Capital Do-Re-Mi and reflect current standard of care.

placebo comparator: Placebo

Participants in the placebo arm will have an intravenous solution of 0.9% NaCl running at a standardized rate, comparable to the infusion rate of the inotrope arm.

Interventions

Dobutamine

Dobutamine administered according to its clinical dose stage for cardiogenic shock

Milrinone

Milrinone administered according to its clinical dose stage for cardiogenic shock

Normal Saline

Normal saline running at a standardized rate

Primary outcome measure

  • Primary composite outcome [ Time Frame: Through duration of hospitalization, up to 12 weeks following admission ]

Central Contacts and Locations

Central contacts

Rebecca Mathew, MD

613-696-7406rmathew@ottawaheart.ca

Baylie Morgan, RN

613-696-7000bmorgan@ottawaheart.ca

Locations

Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Emilie Belley-Cote, MD

905-521-2100

Principal Investigator:

Emilie Belley-Cote, MD

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y4W7

Contacts

Rebecca Mathew, MD

613-696-7406rmathew@ottawaheart.ca

Principal Investigator:

Rebecca Mathew, MD

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

May 1, 2026

Last verified

Mar, 2026

Keywords

  • cardiogenic
  • shock
  • inotrope

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-05-01.