CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

Who is this study for? Patients with Cardiogenic Shock
What treatments are being studied? Dobutamine+Milrinone
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients ≥ 18 years of age admitted to an intensive care unit

• SCAI class C or D cardiogenic shock

Locations
United States
Minnesota
Mayo Clinic
NOT_YET_RECRUITING
Rochester
Other Locations
Canada
Hamilton Health Sciences
RECRUITING
Hamilton
University of Ottawa Heart Institute
RECRUITING
Ottawa
Contact Information
Primary
Rebecca Mathew, MD
rmathew@ottawaheart.ca
613-696-7406
Backup
Baylie Morgan, RN
bmorgan@ottawaheart.ca
613-696-7000
Time Frame
Start Date: 2022-03-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 346
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Ottawa Heart Institute Research Corporation

This content was sourced from clinicaltrials.gov