Predictors of Mortality in Patients With VA-Extracorporeal Membrane Oxygenation. (ECMO)

Predictors of Mortality in Patients With VA-Extracorporeal Membrane Oxygenation. A Retrospective Data Review.

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) support is a lifesaving tool used to treat cardiogenic shock, acute heart failure, or extracorporeal cardiopulmonary resuscitation(CPR). However, its use is associated with significant complications, including mortality. We aim to conduct a retrospective observational study of all patients at Heart Hospital who required VA-ECMO support due to cardiogenic shock during 1/06/2016 and 1/06/2022 to report the incidence of in-hospital mortality among patients who required VA-ECMO along with the predictors of mortality. Data will be collected to identify baseline characteristics and outcomes including clinical variables predictive of poor outcomes.

Study Overview

• Status: Recruiting
• Conditions: Morality; VA-ECMO

Detailed Description

Extracorporeal membrane oxygenation (ECMO) is an advanced life support modality for critically ill patients with refractory cardiac or respiratory failure. It is a temporary support for cardiorespiratory failure, bridging time for recovery or permanent assist. Besides, ECMO could be used in a variety of clinical presentations, such as severe traumas, extracorporeal-assisted rewarming (ECAR) of accidental deep hypothermia, and can be used as a bridge to lung or heart transplant.

Cardiogenic shock can be a fatal condition with poor prognosis. Conventional treatments for cardiogenic shock include vasopressor agents guided by invasive monitoring, and intraaortic balloon pump support. There has been growing interest in the use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) as a salvage therapy for patients in cardiogenic shock refractory to conventional treatments. However, there is a low rate of survival to weaning or bridging therapy among patients with cardiogenic shock requiring ECMO (42-56%). Moreover, VA-ECMO use is associated with complications, including bleeding, renal failure. Thus, the benefits of this potentially life-saving support is still subject to discussion, especially for VA-ECMO use in the setting of cardiogenic shock as the evidence is scarce. Therefore, it important to identify the patients' related factors that may be associated with poor outcomes using real-world data. We will conduct a retrospective observational study of all patients at Heart Hospital who required VA-ECMO support due to cardiogenic shock during 1/06/2016 and 1/06/2022 with the aim of quantifying the incidence of in-hospital mortality among patients who required VA-ECMO in the setting of cardiogenic shock along with determining the predictors of mortality.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Alaa Rahhal, Msc; Phone Number: 44395646; Email: ARahhal1@hamad.qa

Study Locations

• Qatar
  • DA
    • Doha, DA, Qatar, 3050
      • Recruiting
      • Hamad Medical Corporation
      • Contact: Alaa Rahhal, MSc Pharma; Email: ARahhal1@hamad.qa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Requirement of VA-ECMO support

Description

Inclusion Criteria:

• Adults with the age of ≥ 18 years
• Requiring VA-ECMO or VAV-ECMO support

Exclusion Criteria:

• Requiring VV-ECMO support

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	mortality in patients who had VA-ECMO	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bacterial pathogens responsible for infection-related mortality in VA-ECMO	infection	1 month

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): February 28, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: outcome; mortality; VA-ECMO
• Other Study ID Numbers: MRC-01-22-574

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No