Cardiogenic Shock
Conditions
Keywords
Mechanical circulatory support
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.
Interventions
None listed
Sponsors
University of Utah
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular function (ejection fraction) | Day 1/Enrollment | Ejection fraction will be measured via echocardiogram and compared between time points and between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral perfusion per lactate | Daily (days 1-7) | Measurements of lactate will indicate differences in peripheral perfusion between time points and between groups |
| Peripheral perfusion per CO2 gap | Daily (days 1-7) | Measurements of carbon dioxide (CO2) gap will indicate differences in peripheral perfusion between time points and between groups |
| Distension | Day 1/Enrollment | Left ventricular end-diastolic dysfunction (LVEDD) will be measured via echocardiogram and compared between groups and between time points. |
| Cardiac injury per BNP | Daily (days 1-7) | Measurements of B-type natriuretic peptide (BNP) will indicate levels of cardiac injury between time points and between groups. |
| Cardiac injury per cBIN1 | Twice in 7 days | Measurements of cardiac BIN1 (cBIN1) will indicate levels of cardiac injury between time points and between groups. |
| Cardiac injury per troponin | Daily (days 1-7) | Measurements of troponin will indicate levels of cardiac injury between time points and between groups. |
Countries
Canada, United States
Outcome results
None listed