Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation - Beta Receptor Modulation Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

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

• Age ≥ 18 years,

• Having received V-A ECMO support for severe circulatory insufficiency due to left- or bi-ventricular failure.

• ≤ 16 hours after initiation of V-A ECMO support

• Receiving ≥ 2 mcg/kg/min of dobutamine.

• Norepinephrine infusion ≤ 0.4 mcg/kg/min

• Heart rate ≥ 80 bpm (being sinus rhythm, atrial fibrillation or atrial flutter) after V-A ECMO initiation

Locations
Other Locations
Netherlands
Erasmus Medical Center
RECRUITING
Rotterdam
Contact Information
Primary
Christiaan L. Meuwese, MD, PhD
c.meuwese@erasmusmc.nl
0631135752
Backup
Myrthe PJ van Steenwijk, MD
m.p.j.vansteenwijk@erasmusmc.nl
0650162551
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2025-12-03
Participants
Target number of participants: 20
Treatments
Experimental: Beta receptor inhibition arm
In the beta receptor (BR) inhibition arm, patients are randomized to a biphasic strategy where BR stimulation is phased out and esmolol (BR blockade) is initiated in a sequential way. During a first phase, milrinone (a phosphodiesterase inhibitor which is routinely used in V-A ECMO supported patients) infusion will be initiated (if not already being given) at 0.25 mcg/kg/min and dobutamine dosages will be decreased every hour and eventually stopped according to the following sequence; 6 - 4 - 2 - 1 - 0 mcg/kg/min.~In a second phase, esmolol is initiated with a dosage of 25 mcg/kg/min. The dose of the BB will be increased with increments of 25 mcg/kg/min every hour until reaching a heart rate between 50 and 70 bpm or a maximum dose of 200 mcg/kg/min. Prior to each dosage escalation, a reassessment of the hemodynamic situation will be done.~The BR inhibition strategy will be continued until 48 hours after randomization or earlier when deemed necessary by the treating physician.
No_intervention: Routine care arm
The dosage of dobutamine infusion is at the discretion of the treating physician but is typically continued until 48 hours after randomization. All other medication will be managed according to the needs of the patient at the discretion of the treating physician.
Sponsors
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov