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Inotrope

Inotrope Therapy for Cardiogenic Shock (DOREMI-2 Trial)

Phase 4

Recruiting

Led By Rebecca Mathew, MD

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

SCAI class C or D cardiogenic shock

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through duration of hospitalization, up to 12 weeks following admission

Awards & highlights

DOREMI-2 Trial Summary

This trial is testing whether two commonly used heart medications are more effective than a placebo in treating critically ill patients.

Who is the study for?

This trial is for adults over 18 in intensive care with a severe form of heart failure called cardiogenic shock. It's not for pregnant or breastfeeding individuals, those who can't consent, had an out-of-hospital cardiac arrest, took certain heart medications recently, or have specific severe heart valve problems.Check my eligibility

What is being tested?

The study tests if drugs that boost the heart's pumping ability (inotropes) help critically ill patients. Participants will randomly receive either Milrinone, Dobutamine, or a placebo without knowing which one. After 12 hours they may continue treatment based on their doctor’s decision.See study design

What are the potential side effects?

Possible side effects from Milrinone and Dobutamine include irregular heartbeat, blood pressure changes, headaches, nausea and potential worsening of the condition being treated. The exact side effects will vary between individuals.

DOREMI-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe heart failure.

Select...

I am 18 or older and currently in intensive care.

DOREMI-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through duration of hospitalization, up to 12 weeks following admission

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through duration of hospitalization, up to 12 weeks following admission

This trial's timeline: 3 weeks for screening, Varies for treatment, and through duration of hospitalization, up to 12 weeks following admission for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary composite outcome

Secondary outcome measures

All-cause in-hospital mortality

Atrial or ventricular arrhythmia leading to emergent electrical cardioversion

Need for cardiac transplant or mechanical circulatory support

+4 more

Other outcome measures

Acute kidney injury

Arrhythmia requiring pharmacologic intervention

Need for non-invasive or invasive mechanical ventilation

DOREMI-2 Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: InotropeActive Control2 Interventions

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor

188 Previous Clinical Trials

92,090 Total Patients Enrolled

Rebecca Mathew, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation

Media Library

Dobutamine (Inotrope) Clinical Trial Eligibility Overview. Trial Name: NCT05267886 — Phase 4

Cardiogenic Shock Research Study Groups: Inotrope, Placebo

Cardiogenic Shock Clinical Trial 2023: Dobutamine Highlights & Side Effects. Trial Name: NCT05267886 — Phase 4

Dobutamine (Inotrope) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05267886 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants to enroll in this experiment?

"Affirmative. Clinicaltrials.gov shows that this clinical trial is currently recruiting participants, having first been posted on March 5th 2022 and last edited on the 14th of the same month. The study requires 346 patients from one site to take part in it."

Answered by AI

Are there any known safety risks associated with Inotrope?

"The safety of Inotrope has been assessed to be a 3 since this is Phase 4, which indicates that it has achieved approval."

Answered by AI

How many participants has this research initiative enrolled?

"Affirmative. The information on clinicaltrials.gov corroborates that this medical investigation is currently recruiting participants, with the first posting being dated 5th March 2022 and last updated 14th March 2022. A total of 346 study volunteers are required across one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

2022. "CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05267886.