Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation (REMAP ECMO)
- Conditions
- Cardiogenic shockHeart failure10019280
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 430
- Having received ECMO support for severe circulatory and/or respiratory
insufficiency.
- Age >= 18 years
- Cardiogenic shock
- Initiation of intra-aortic balloon pump (IABP) possible <= 8 hours after ECMO
initiation
- Raised objection during the deferred consent procedure
- ECMO usage confined to the period during surgery or another intervention (the
ECMO was
removed at the end of the intervention).
- Isolated right ventricular failure (e.g. due to pulmonary embolism).
- Left ventricular assist device (LVAD), Impella or IABP in situ.
- Ventricular septal defect or papillary muscle rupture as the cause of shock.
- Thoracic or abdominal aortic dissection.
- Moderate or severe aortic regurgitation
- Mechanical prosthesis in mitral valve position
- Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Successful ECMO weaning at 30 days, defined by; a) being alive, b) without<br /><br>ECMO, IABP or Impella support, and c) not having received a heart<br /><br>transplantation or left ventricular assist device (LVAD).<br /><br><br /><br>For the physiological substudy:<br /><br>The difference in left ventricular end diastolic volume (as estimated by<br /><br>transesophageal echocardiography) measured at the first time point (after<br /><br>hemodynamic stabilization (defined by stable hemodynamic parameters such as<br /><br>blood pressure and heart rate, and adequate ECMO flow) and within 24h after<br /><br>ECMO initiation) in the cohort of patients supported by V-A ECMO with- versus<br /><br>without- IABP at baseline (mechanical ventilation set at clinical PEEP).</p><br>
- Secondary Outcome Measures
Name Time Method