Establishing Physiologic Outcomes for Ventricular Unloading on VA ECMO

Cardiogenic Shock Clinical Trial

Official title:

Establishing Physiologic Outcomes for Ventricular Unloading on VA ECMO

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05658276
• Other study ID #: 142543
• Status: Recruiting
• Start date: December 15, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: University of Utah
• Contact: Joseph E Tonna, MD
• Phone: 801-581-5311
• Email: joseph.tonna[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock, Cardiogenic

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (8)

Aissaoui N, Luyt CE, Leprince P, Trouillet JL, Leger P, Pavie A, Diebold B, Chastre J, Combes A. Predictors of successful extracorporeal membrane oxygenation (ECMO) weaning after assistance for refractory cardiogenic shock. Intensive Care Med. 2011 Nov;37(11):1738-45. doi: 10.1007/s00134-011-2358-2. Epub 2011 Oct 1. — View Citation

Combes A, Price S, Slutsky AS, Brodie D. Temporary circulatory support for cardiogenic shock. Lancet. 2020 Jul 18;396(10245):199-212. doi: 10.1016/S0140-6736(20)31047-3. — View Citation

Eckman PM, Katz JN, El Banayosy A, Bohula EA, Sun B, van Diepen S. Veno-Arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock: An Introduction for the Busy Clinician. Circulation. 2019 Dec 10;140(24):2019-2037. doi: 10.1161/CIRCULATIONAHA.119.034512. Epub 2019 Dec 9. — View Citation

Hitzeman TC, Xie Y, Zadikany RH, Nikolova AP, Baum R, Caldaruse AM, Agvanian S, Melmed GY, McGovern DPB, Geft DR, Chang DH, Moriguchi JD, Hage A, Azarbal B, Czer LS, Kittleson MM, Patel JK, Wu AHB, Kobashigawa JA, Hamilton M, Hong T, Shaw RM. cBIN1 Score (CS) Identifies Ambulatory HFrEF Patients and Predicts Cardiovascular Events. Front Physiol. 2020 May 25;11:503. doi: 10.3389/fphys.2020.00503. eCollection 2020. — View Citation

Kim D, Jang WJ, Park TK, Cho YH, Choi JO, Jeon ES, Yang JH. Echocardiographic Predictors of Successful Extracorporeal Membrane Oxygenation Weaning After Refractory Cardiogenic Shock. J Am Soc Echocardiogr. 2021 Apr;34(4):414-422.e4. doi: 10.1016/j.echo.2020.12.002. Epub 2020 Dec 13. — View Citation

Nikolova AP, Hitzeman TC, Baum R, Caldaruse AM, Agvanian S, Xie Y, Geft DR, Chang DH, Moriguchi JD, Hage A, Azarbal B, Czer LS, Kittleson MM, Patel JK, Wu AHB, Kobashigawa JA, Hamilton M, Hong T, Shaw RM. Association of a Novel Diagnostic Biomarker, the Plasma Cardiac Bridging Integrator 1 Score, With Heart Failure With Preserved Ejection Fraction and Cardiovascular Hospitalization. JAMA Cardiol. 2018 Dec 1;3(12):1206-1210. doi: 10.1001/jamacardio.2018.3539. — View Citation

Rao P, Khalpey Z, Smith R, Burkhoff D, Kociol RD. Venoarterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock and Cardiac Arrest. Circ Heart Fail. 2018 Sep;11(9):e004905. doi: 10.1161/CIRCHEARTFAILURE.118.004905. — View Citation

Tonna J, Selzman C, Bartos J, Presson A, Jo Y, Becker LB, Youngquist ST, Thiagarajan RR, Johnson A, Rycus P, Keenan H. Abstract 117: Critical Care Management, Hospital Case Volume, and Survival After Extracorporeal Cardiopulmonary Resuscitation. Circulation. 2020 2020/11/17;142(Suppl_4):A117-A117. doi: 10.1161/circ.142.suppl_4.117.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular function (ejection fraction)	Ejection fraction will be measured via echocardiogram and compared between time points and between groups	Day 1/Enrollment
Primary	Left ventricular function (ejection fraction)	Ejection fraction will be measured via echocardiogram and compared between time points and between groups	After LV unloading (within the first week of ECMO treatment; no specific day as this is a clinical decision)
Primary	Left ventricular function (ejection fraction)	Ejection fraction will be measured via echocardiogram and compared between time points and between groups	Day 5
Secondary	Distension	Left ventricular end-diastolic dysfunction (LVEDD) will be measured via echocardiogram and compared between groups and between time points.	Day 1/Enrollment
Secondary	Distension	Left ventricular end-diastolic dysfunction (LVEDD) will be measured via echocardiogram and compared between groups and between time points.	After LV unloading (within the first week of ECMO treatment; no specific day as this is a clinical decision)
Secondary	Distension	Left ventricular end-diastolic dysfunction (LVEDD) will be measured via echocardiogram and compared between groups and between time points.	Day 5
Secondary	Peripheral perfusion per lactate	Measurements of lactate will indicate differences in peripheral perfusion between time points and between groups	Daily (days 1-7)
Secondary	Peripheral perfusion per CO2 gap	Measurements of carbon dioxide (CO2) gap will indicate differences in peripheral perfusion between time points and between groups	Daily (days 1-7)
Secondary	Cardiac injury per troponin	Measurements of troponin will indicate levels of cardiac injury between time points and between groups.	Daily (days 1-7)
Secondary	Cardiac injury per BNP	Measurements of B-type natriuretic peptide (BNP) will indicate levels of cardiac injury between time points and between groups.	Daily (days 1-7)
Secondary	Cardiac injury per cBIN1	Measurements of cardiac BIN1 (cBIN1) will indicate levels of cardiac injury between time points and between groups.	Twice in 7 days