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Physiology of Unloading VA ECMO Trial

ConditionCardiogenic Shock
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • IABP

    Device

    LV unloading via intra-aortic balloon pump (IABP)

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: With LV UnloadingExperimental treatment 1 intervention
Group B: Without LV UnloadingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in pulmonary capillary wedge pressure

Change in pulmonary capillary wedge pressure (PCWP) from ECMO start to ECMO day 5 (Day 5 - Baseline) with and without LV unloading

Time frame
ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months

Secondary outcomes

1

Change in pulmonary artery diastolic pressure

Change in pulmonary artery diastolic pressure (PADP) from ECMO start to ECMO day 5 (Day 5 - baseline) with and without LV unloading

Time frame
ECMO start, ECMO days 1-5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
2

Change in left ventricular end diastolic diameter

Change in left ventricular end diastolic diameter (LVEDd) from ECMO start to ECMO day 5 (Day 5 - baseline) with and without LV unloading

Time frame
ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
3

Change in N-terminal pro b-type natriuretic peptide

Change in N-terminal pro b-type natriuretic peptide (NT-pro BNP) from ECMO start to ECMO day 5 (Day 5 - baseline) with and without LV unloading

Time frame
ECMO start, ECMO days 1-5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months
4

Hemodynamic stability

Hemodynamic stability (defined as a change in mean arterial pressure \[MAP\] from prior to turn down until 2 minutes of wean) at ECMO day 5 with and without LV unloading

Time frame
ECMO start, ECMO day 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

University of Minnesota

Collaborator

Source ClinicalTrials.gov
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