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Physiology of Unloading VA ECMO Trial

RecruitingPhase 2Ages 18 Years - anyAllUniversity of Utah
NCT06336655 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for cardiogenic shock (CS). The main aims of the study are: 1. To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO 2. To determine the effects on myocardial function of adding LV unloading to ECMO 3. To test the effects on myocardial recovery of adding LV unloading to VA ECMO Participants who are being treated with VA ECMO will be randomized to receive or not receive LV unloading in the form of an intra-aortic balloon pump (IABP). Over the course of the study, the investigators will obtain measurements via lab work, echocardiography, and pulmonary artery catheter that will allow comparison of the two groups.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients (age 18 years or older) * Diagnosis of acute cardiogenic shock (CS) * Patients failing medical therapy, defined as 1 or more of the following: 1. Society for Coronary Angiography and Interventions (SCAI) Stage C or greater 2. 2 or more inotropic medications and not improving 3. IABP in place and clinically worsening 4. Placed on VA ECMO for CS 5. In the opinion of the attending physician, patient has worsening CS and could require VA ECMO support in the near-term Exclusion Criteria: * Metastatic or stage 4 cancer * Atrial septostomy * Planned LV unloading on ECMO * Anticipated death \<72 hours * Existing durable left ventricular assist device (dLVAD) * Unwillingness to randomize * Patients who are pregnant
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What it tests

  • IABP
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Where

1 site
University of Utah
Salt Lake City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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