Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06522594

REMAP ECMO - Beta Receptor Modulation Trial

Led by Erasmus Medical Center · Updated on 2024-07-26

20

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In this phase 2, single center, randomized clinical pilot trial, investigators will study the effect of a strategy involving a reduction of beta receptor (BR) stimulation (by decreasing dobutamine dosages) and subsequent BR inhibition (through ultra-short acting betablockers), versus a (routine) strategy with continued BR stimulation through dobutamine infusion, on heart rate in patients with cardiogenic shock due to left- or bi-ventricular failure being supported by V-A ECMO.

CONDITIONS

Official Title

REMAP ECMO - Beta Receptor Modulation Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 63 18 years
  • Receiving V-A ECMO support for severe circulatory insufficiency due to left- or bi-ventricular failure
  • Initiated V-A ECMO support 64 16 hours ago
  • Receiving dobutamine infusion at 2 mcg/kg/min or higher
  • Norepinephrine infusion at 0.4 mcg/kg/min or lower
  • Heart rate 80 bpm or higher after V-A ECMO initiation, including sinus rhythm, atrial fibrillation, or atrial flutter
Not Eligible

You will not qualify if you...

  • Objection during the deferred consent procedure
  • V-A ECMO used only during surgery or intervention and removed afterward
  • Having a durable Left Ventricular Assist Device (LVAD)
  • Polymorphic ventricular tachycardia requiring beta blocker therapy
  • Isolated right ventricular failure (e.g., due to pulmonary embolism)
  • Need for high dose dobutamine greater than 6.0 mcg/kg/min
  • Receiving epinephrine infusion
  • Signs of insufficient trans cardiac flow, including absence of aortic valve opening, pulse pressure less than 10 mmHg with intra-aortic balloon pump standby, or spontaneous contrast in the heart on echocardiography
  • Contraindications, intolerance, or allergy to esmolol
  • Second- or third-degree AV block
  • Pregnancy
  • Life expectancy less than 24 hours
  • Participation in another randomized clinical trial
  • Unable to start study treatment within 4 hours after randomization
  • Post heart transplantation patients

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Erasmus Medical Center

Rotterdam, South Holland, Netherlands, 3015GD

Actively Recruiting

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Research Team

C

Christiaan L. Meuwese, MD, PhD

CONTACT

M

Myrthe PJ van Steenwijk, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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