CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

Conditions

• Shock, Cardiogenic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dobutamine — DRUG
  Dobutamine administered according to its clinical dose stage for cardiogenic shock
• Milrinone — DRUG
  Milrinone administered according to its clinical dose stage for cardiogenic shock
• Normal Saline — DRUG
  Normal saline running at a standardized rate

Study Details

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.

Key Dates

Start date

Mar 5, 2022

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

346 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Rebecca Mathew, MD
  613-696-7406
  [email protected]
• Baylie Morgan, RN
  613-696-7000
  [email protected]

Locations (1)

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