Physiology of Unloading VA ECMO Trial

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT06336655
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cardiogenic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IABP — DEVICE
    LV unloading via intra-aortic balloon pump (IABP)

Study Details

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.

Key Dates

Start date
Oct 2, 2024
Status verified
Apr 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: With LV Unloading
    Patients on VA ECMO who randomize to receive LV unloading
  • No Intervention: Without LV Unloading
    Patients on VA ECMO who randomize to receive no LV unloading

Primary Outcome Measure

Change in pulmonary capillary wedge pressure [ Time Frame: ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84132
Joseph E. Tonna, MD, FAAEM
[email protected]
801.587.9373

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By research site
University of Utah· Salt Lake City, UT

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