Clinical trial NCT05730894: Predictors of Mortality in Patients With VA-Extracorporeal Membrane Oxygenation.
Official title: Predictors of Mortality in Patients With VA-Extracorporeal Membrane Oxygenation. A Retrospective Data Review.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morality
VA-ECMO
Keywords: mortality
VA-ECMO
outcome
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2023-02-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Requirement of VA-ECMO support

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Requiring VV-ECMO support

Primary outcomes:
measure: mortality
timeFrame: 6 months
Secondary outcomes:
measure: bacterial pathogens responsible for infection-related mortality in VA-ECMO
timeFrame: 1 month
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad medical corporation
state: DA
Study officials:
References: