Establishing Physiologic Outcomes for Ventricular Unloading on VA ECMO
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiogenic Shock
- Sponsor
- University of Utah
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Left ventricular function (ejection fraction)
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
Aim 1: Prospective, observational analysis of the association between echocardiographic measures of cardiac function and left ventricular unloading on VA ECMO.
Aim 2: Prospective, observational analysis of the association between clinical laboratory biomarkers and left ventricular unloading on VA ECMO.
Detailed Description
Mechanical circulatory support (MCS) is increasingly utilized as a means of hemodynamic support among cardiogenic shock (CS) patients refractory to optimal medical management. MCS modalities include using either an intra-aortic balloon pump (IABP), Impella®, or ECMO, each with unique benefit/harm profiles. Among the various MCS devices, extracorporeal membrane oxygenation (ECMO) is described as the highest level of support, capable of providing 5+ liters per minute of oxygenated blood flow but is the most invasive. Despite the benefit of maximal cardiopulmonary support, ECMO increases afterload in a failing heart. Left ventricular (LV) unloading or decompression (using simultaneous IABP or Impella®) has been suggested as potential improvement. Observational studies suggest a benefit with LV unloading during VA ECMO for CS, but the mechanisms underlying the association are poorly understood. Prior to trials, a mechanistic understanding of the effect of different LV unloading strategies on key physiologic abnormalities in CS is needed, as the physiologic effects of LV unloading during VA ECMO for CS remain insufficiently defined. The objective of this study is to define serial changes in common clinical variables routinely obtained during management of patients in CS. These clinical variables are readily accessible to clinicians, but are not typically collected in a sufficiently granular serial manner to characterize their utility as clinical biomarkers. By obtaining scheduled assessments, repeated in a prospective cohort over the clinical course of CS, the investigators will define the physiologic effects of different LV unloading strategies in cardiogenic shock. We will examine a) echocardiographic measures of ventricular distension, and b) blood biochemical measures of peripheral perfusion.
Investigators
Joseph Tonna
Associate Professor, Division of Cardiothoracic Surgery
University of Utah
Eligibility Criteria
Inclusion Criteria
- •Patients who are 18 years of age or older
- •Patients with cardiogenic shock
- •Patients with mechanical circulatory support, specifically veno-arterial extracorporeal membrane oxygenation (VA ECMO) inserted peripherally
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Left ventricular function (ejection fraction)
Time Frame: Day 5
Ejection fraction will be measured via echocardiogram and compared between time points and between groups
Secondary Outcomes
- Cardiac injury per cBIN1(Twice in 7 days)
- Distension(Day 5)
- Cardiac injury per BNP(Daily (days 1-7))
- Cardiac injury per troponin(Daily (days 1-7))
- Peripheral perfusion per lactate(Daily (days 1-7))
- Peripheral perfusion per CO2 gap(Daily (days 1-7))