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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05730894
Other study ID # MRC-01-22-574
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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