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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiogenic Shock; Extracorporeal Membrane Oxygenation Complication
• Intervention / Treatment: Procedure: ECMO

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Suraj Sudarsanan, MD; Phone Number: 44395897; Email: Sudarsanan@hamad.qa
• Study Contact Backup: Name: Praveen Sivadasan, MD; Email: drpraveencs@gmail.com

Study Locations

• Qatar
  • DA
    • Doha, DA, Qatar, 3050
      • Recruiting
      • Hamad Medical Corporation
      • Contact: Suraj Sudarsanan, MD; Email: ssudarsanan@hamad.qa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will be undertaken in the Cardiothoracic intensive care unit (CTICU) in the Heart hospital, Hamad Medical Corporation for patients who require VA-ECMO support

Description

• Inclusion criteria

  • Age more than18 years old.
  • Patients undergoing institution of VA ECMO

• Exclusion criteria

  • Patients staying < 12 hours in the ICU

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival predictive accuracy of four scores	Survival predictive accuracy of four scores	6 months

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation
• Investigators: Principal Investigator: Suraj Sudarsanan, Md, Hamad medical coproation

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Shock, Cardiogenic
• Other Study ID Numbers: MRC-01-22-701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No