RECRUITING

CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

Quick Facts

Study Start:2022-03-05
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05267886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients ≥ 18 years of age admitted to an intensive care unit
  2. * SCAI class C or D cardiogenic shock
  1. * Unwilling or unable to obtain informed consent by the participant or substitute decision maker
  2. * Patients who are currently pregnant or breast-feeding
  3. * Patients presenting with an out-of-hospital cardiac arrest (OHCA)
  4. * Administration of milrinone or dobutamine in the 24 hours preceding anticipated randomization
  5. * Severe obstructive valvular lesions, including aortic stenosis and/or mitral stenosis
  6. * Dynamic left ventricular outflow tract obstruction

Contacts and Locations

Study Contact

Rebecca Mathew, MD
CONTACT
613-696-7406
rmathew@ottawaheart.ca
Baylie Morgan, RN
CONTACT
613-696-7000
bmorgan@ottawaheart.ca

Principal Investigator

Rebecca Mathew, MD
PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Ottawa Heart Institute Research Corporation

  • Rebecca Mathew, MD, PRINCIPAL_INVESTIGATOR, Ottawa Heart Institute Research Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-05
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-03-05
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • cardiogenic
  • shock
  • inotrope

Additional Relevant MeSH Terms

  • Shock, Cardiogenic