drugset / Trial / NCT05267886

CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

NCT05267886

Phase 4 Recruiting 346 enrolled Ottawa Heart Institute Research Corporation
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2022-03-05
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dobutamine Small molecule 2.5 ug/kg
Comparator Dobutamine Small molecule 5 ug/kg
Comparator Dobutamine Small molecule 7.5 ug/kg
Comparator Dobutamine Small molecule 10 ug/kg
Comparator Milrinone Small molecule 0.125 ug/kg
Comparator Milrinone Small molecule 0.25 ug/kg
Comparator Milrinone Small molecule 0.375 ug/kg
Comparator Milrinone Small molecule 0.5 ug/kg

Indications