Physiology of Unloading VA ECMO Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

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.

Eligibility criteria

Qualifiers

Adult patients (age 18 years or older)

Diagnosis of acute cardiogenic shock (CS)

Society for Coronary Angiography and Interventions (SCAI) Stage C or greater

2 or more inotropic medications and not improving

Disqualifiers

Metastatic or stage 4 cancer

Atrial septostomy

Planned LV unloading on ECMO

Anticipated death <72 hours

Trial design

Treatments tested in this trial

  • IABP

Treatment groups

104 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Utah

Lead sponsor

University of Minnesota

Collaborator