Physiology of Unloading VA ECMO Trial

Description

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.

Conditions

Cardiogenic Shock

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Study Overview

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Study Details

Study overview

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.

Physiology of Unloading VA ECMO Trial

Physiology of Unloading VA ECMO Trial

Condition
Cardiogenic Shock
Intervention / Treatment

-

Contacts and Locations

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Utah,

Study Record Dates

2029-02-01