RECRUITING

Physiology of Unloading VA ECMO Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Physiology of Unloading VA ECMO Trial

Quick Facts

Study Start:2024-10-02
Study Completion:2029-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06336655

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients (age 18 years or older)
  2. * Diagnosis of acute cardiogenic shock (CS)
  3. * Patients failing medical therapy, defined as 1 or more of the following:
  4. 1. Society for Coronary Angiography and Interventions (SCAI) Stage C or greater
  5. 2. 2 or more inotropic medications and not improving
  6. 3. IABP in place and clinically worsening
  7. 4. Placed on VA ECMO for CS
  8. 5. In the opinion of the attending physician, patient has worsening CS and could require VA ECMO support in the near-term
  1. * Metastatic or stage 4 cancer
  2. * Atrial septostomy
  3. * Planned LV unloading on ECMO
  4. * Anticipated death \<72 hours
  5. * Existing durable left ventricular assist device (dLVAD)
  6. * Unwillingness to randomize
  7. * Patients who are pregnant

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-02
Study Completion Date2029-02-01

Study Record Updates

Study Start Date2024-10-02
Study Completion Date2029-02-01

Terms related to this study

Keywords Provided by Researchers

  • cardiogenic shock
  • extracorporeal membrane oxygenation
  • left ventricular unloading

Additional Relevant MeSH Terms

  • Cardiogenic Shock