Physiology of Unloading VA ECMO Trial
University of Utah
Summary
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.
Description
Although extracorporeal membrane oxygenation (ECMO) for cardiogenic shock (CS) is used in over 3,000 patients per year, the best management strategies are not known. Identifying and improving treatment of CS is critically important, as CS occurs in 160,000 patients per year in the US with a 50% mortality rate. VA ECMO is an increasingly used method of mechanical circulatory support (MCS) for patients with CS refractory to medical therapy. Despite the benefit of full cardiopulmonary support ECMO is also thought to increase after load in the failing heart- which paradoxically reduces cardiac out…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceIABP
LV unloading via intra-aortic balloon pump (IABP)
Location
- University of UtahSalt Lake City, Utah