Comparison of Four Intensive Care Scores in Prediction of VA-ECMO Survival.

Cardiogenic Shock Clinical Trial

— ECMO  

Official title:

Comparison of Four Intensive Care Scores in Prediction of Survival After Veno-Arterial ECMO: A Single Center Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730881
• Other study ID #: MRC-01-22-701
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Extracorporeal Membrane Oxygenation Complication
• Shock, Cardiogenic

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