Establishing Physiologic Outcomes for Ventricular Unloading on VA ECMO

NCT05658276 | Withdrawn

• 1 other identifier: 142543
• Study Type: observational
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cardiogenic Shock

Keywords

Mechanical circulatory support

Outcome Measures

Primary Outcomes (3)

• Left ventricular function (ejection fraction)

  Ejection fraction will be measured via echocardiogram and compared between time points and between groups

  Day 1/Enrollment

• 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)

• Left ventricular function (ejection fraction)

  Ejection fraction will be measured via echocardiogram and compared between time points and between groups

  Day 5

Secondary Outcomes (8)

• Distension

  Day 1/Enrollment

• Distension

  After LV unloading (within the first week of ECMO treatment; no specific day as this is a clinical decision)

• Distension

  Day 5

• Peripheral perfusion per lactate

  Daily (days 1-7)

• Peripheral perfusion per CO2 gap

  Daily (days 1-7)

Study Arms (2)

With LV Unloading

Adults (18+) who are in cardiogenic shock and being treated with mechanical circulatory support (veno-arterial ECMO) inserted peripherally. The patients in this group will also have an additional device, such as an Impella or an intra-aortic balloon pump (IABP) for left ventricular unloading. The decision whether or not to unload the patient will be purely clinical. Data will be collected from the patient's chart and entered into a secure database. A standard complete transthoracic echocardiogram will be completed at enrollment and then again 7 days from enrollment (+/- 2 days). Additional blood tests will be ordered for the 7 days after enrollment. All tests will be ordered on Day 1 (patient on ECMO, prior to any LV unloading) and additionally as follows: * Troponin: Daily for 7 days * NT-proBNP: Daily for 7 days * PCO2 gap (in blood gas analysis): Every 6 hours for 3 days * Lactate (in blood gas analysis): Every 12 hours for 3 days * cBIN1: Twice in 7 days

Without LV Unloading

Adults (18+) who are in cardiogenic shock and being treated with mechanical circulatory support (veno-arterial ECMO) inserted peripherally. The patients in this group will not have any LV unloading device in addition to the ECMO support. The decision not to do LV unloading will be purely clinical. Data will be collected from the patient's chart and entered into a secure database. A standard complete transthoracic echocardiogram will be completed at enrollment and then again 7 days from enrollment (+/- 2 days). Additional blood tests will be ordered for the 7 days after enrollment. All tests will be ordered on Day 1 (patient on ECMO, prior to any LV unloading) and additionally as follows: * Troponin: Daily for 7 days * NT-proBNP: Daily for 7 days * PCO2 gap (in blood gas analysis): Every 6 hours for 3 days * Lactate (in blood gas analysis): Every 12 hours for 3 days * cBIN1: Twice in 7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to our facility in cardiogenic shock.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Utah: lead

Study Sites (2)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Toronto

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (8)

• Tonna JE, Selzman CH, Bartos JA, Presson AP, Ou Z, Jo Y, Becker L, Youngquist ST, Thiagarajan RR, Johnson MA, Rycus P, Keenan HT. The Association of Modifiable Postresuscitation Management and Annual Case Volume With Survival After Extracorporeal Cardiopulmonary Resuscitation. Crit Care Explor. 2022 Jul 25;4(7):e0733. doi: 10.1097/CCE.0000000000000733. eCollection 2022 Jul.

  PMID: 35923595 BACKGROUND

• 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.

  PMID: 30354364 BACKGROUND

• 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.

  PMID: 32670075 BACKGROUND

• 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.

  PMID: 30383171 BACKGROUND

• 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.

  PMID: 31815538 BACKGROUND

• 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.

  PMID: 32682486 BACKGROUND

• 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.

  PMID: 33321165 BACKGROUND

• 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.

  PMID: 21965097 BACKGROUND

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Cardiothoracic Surgery

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: December 20, 2022
• Study Start: December 15, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-03

Locations

US (1); CA (1)