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

Morality Clinical Trial

— ECMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730894
• Other study ID #: MRC-01-22-574
• Status: Recruiting
• Start date: February 28, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2022
• Source: Hamad Medical Corporation
• Contact: Alaa Rahhal, Msc
• Phone: 44395646
• Email: ARahhal1[@]hamad.qa
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults with the age of = 18 years

• Requiring VA-ECMO or VAV-ECMO support

Exclusion Criteria:

• Requiring VV-ECMO support

Related Conditions & MeSH terms

• Morality

Locations

Country	Name	City	State
Qatar	Hamad medical corporation	Doha	DA

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	mortality in patients who had VA-ECMO	6 months
Secondary	bacterial pathogens responsible for infection-related mortality in VA-ECMO	infection	1 month