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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05730881
Other study ID # MRC-01-22-701
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 30, 2023
Est. completion date November 30, 2023

Study information

Verified date November 2022
Source Hamad Medical Corporation
Contact Suraj Sudarsanan, MD
Phone 44395897
Email Sudarsanan@hamad.qa
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

VA-ECMO is increasingly utilized in the setting of cardiogenic shock or cardiac arrest to restore hemodynamic stability and end organ function. VA-ECMO serves as a short-term ventricular assist device that can be rapidly placed at the bedside in the emergency room, intensive care unit, cardiac catheterization suite, or operating room. A bridge to decision approach allows for the assessment of neurologic status, renal and hepatic function, and subsequent recovery of cardiac function. Despite its life-saving potential, VA-ECMO is fraught with complications including vascular complications from cannulation. In addition, neurologic injury, renal failure, liver failure, and sepsis are all well described sequelae of the post-cardiogenic shock or cardiac arrest VA-ECMO patient. For these reasons, identifying early prognostic indicators and developing a score with regard to the outcome of this special patient population is of high interest. The proposed study aims to analyze 4 ICU scores/Survival prediction models [APACHE-II (acute physiology and chronic health evaluation II), SAVE (Survival after VA ECMO) , SOFA (sequential organ failure assessment )and CASUS (Cardiac Surgery Score)] and evaluate their performance in predicting survival after VA ECMO insertion. This will be a clinical retrospective study which will be conducted in the Cardiothoracic Intensive Care unit (CTICU) in the Department of Cardiothoracic Surgery, Heart Hospital, Doha. Patients admitted to the CTICU after institution of VA ECMO in the period between 1st January 2015 to 31st October 2022 will be screened retrospectively. Patients who stay for at least 12 hours in the CTICU would be eligible for inclusion in the study. All charts of patients who were admitted to CTICU after institution of VA ECMO during the afore mentioned period will be included in the review. All the risk scores would be calculated separately for all the enrolled patients and then subjected to statistical analysis to determine predictive accuracy for survival.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date November 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility - Inclusion criteria - Age more than18 years old. - Patients undergoing institution of VA ECMO - Exclusion criteria - Patients staying < 12 hours in the ICU

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
ECMO
VA-ECMO is a life support measures, we need to estimate the survival by different techniques to allocate therapeutic interventions properly

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 Survival predictive accuracy of four scores Survival predictive accuracy of four scores 6 months
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