Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation
Background
Extracorporeal membrane oxygenation (ECMO) can be of lifesaving effect in patients with severe and refractory circulatory and/or respiratory failure. Nevertheless, even today, 30-70 percent of patients cannot be weaned from ECMO support and up to 50 percent of all patients die within one year. In order to improve these weaning failure- and mortality- rates it is crucial to generate evidence on optimum treatment strategies.
REMAP ECMO is a registry-based platform in which multiple randomized controlled trials (RCTs) (trial domains) can be embedded.
Objectives
- Quality monitoring through an overarching patient registry (Dutch ECLS study group)
- Generating answers to pending questions on ECMO patient management through embedded randomized clinical trial domains
Left ventricular unloading trial domain
Objective
To study the effects of left ventricular unloading by means of IABP as an adjunct to VA ECMO versus VA ECMO alone on ECMO weaning success, mortality, quality of life and cost-effectiveness
Trial design
- Adaptivity through response adaptive randomization (RAR) and early trial cessation for reasons of efficacy or futility
- Bayesian statistical framework
- Deferred consent procedure
Trial progression status
Status of the progress inclusions REMAP-ECMO studies.
Trial Progression LV unloading trial
Included patients from 15 participating hospitals
- 116 of 430 27.0%
For Patients
ECMO temporarily takes over the function of the heart and lungs. However, an important disadvantage of ECMO is that it could further stress the failing heart. This can lead to problems such as fluid build-up in the lungs and blood clots. A balloon pump (IABP) can help relieve the pressure on the heart. Currently, it is unknown whether adding a balloon pump to ECMO therapy will improve ECMO treatment. With this study, we will find out whether therapy with only ECMO or ECMO combined with a balloon pump is better. This will lead to improvement of ECMO therapy.
Beta receptor modulation trial domain
Objectives
To study the effect of beta-receptor (BR) inhibition versus BR stimulation on heart rate in patients with cardiogenic shock supported by V-A ECMO
Trial Progression BR modulation trial
- 5 of 20 25%
For Patients
The use of betablockers in ECMO patients
Patients undergoing ECMO treatment suffer from severe heart failure, making it challenging for their hearts to recover. Starting beta blocker medication early, while patients are still on ECMO, might help the heart recover faster. Beta blockers have been proven to be effective in patients with less severe heart failure. However, its effectiveness in ECMO patients is currently unknown. This study aims to determine if starting beta blocker therapy in an early phase during ECMO treatment is safe and helpful. If successful, this approach could lead to faster and improved heart recovery in ECMO patients.
REMAP ECMO Trial Progression
Registry patients
Active sites registry
LV unloading trial
BR modulation trial
REMAP ECMO Team
Christiaan Meuwese
Principal Investigator
Myrthe van Steenwijk
Phd Candidate
Partners
