Clinical trial NCT05658276: Establishing Physiologic Outcomes for Ventricular Unloading on VA ECMO
Official title: Establishing Physiologic Outcomes for Ventricular Unloading on VA ECMO
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiogenic Shock
Keywords: Mechanical circulatory support
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to our facility in cardiogenic shock.

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.

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:

* None

Primary outcomes:
measure: Left ventricular function (ejection fraction)
timeFrame: Day 1/Enrollment
measure: Left ventricular function (ejection fraction)
timeFrame: After LV unloading (within the first week of ECMO treatment; no specific day as this is a clinical decision)
measure: Left ventricular function (ejection fraction)
timeFrame: Day 5
Secondary outcomes:
measure: Distension
timeFrame: Day 1/Enrollment
measure: Distension
timeFrame: After LV unloading (within the first week of ECMO treatment; no specific day as this is a clinical decision)
measure: Distension
timeFrame: Day 5
measure: Peripheral perfusion per lactate
timeFrame: Daily (days 1-7)
measure: Peripheral perfusion per CO2 gap
timeFrame: Daily (days 1-7)
measure: Cardiac injury per troponin
timeFrame: Daily (days 1-7)
measure: Cardiac injury per BNP
timeFrame: Daily (days 1-7)
measure: Cardiac injury per cBIN1
timeFrame: Twice in 7 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
References:
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