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

Sponsor
Hamad Medical Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05730881
Collaborator
(none)
200
1
8
24.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ECMO

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Comparison of Four Intensive Care Scores in Prediction of Survival After Veno-Arterial ECMO: A Single Center Retrospective Study
Anticipated Study Start Date :
Mar 30, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Survival predictive accuracy of four scores [6 months]

    Survival predictive accuracy of four scores

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • Inclusion criteria

  • Age more than18 years old.

  • Patients undergoing institution of VA ECMO

  • Exclusion criteria

  • Patients staying < 12 hours in the ICU

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hamad medical corporation Doha DA Qatar 3050

Sponsors and Collaborators

  • Hamad Medical Corporation

Investigators

  • Principal Investigator: Suraj Sudarsanan, Md, Hamad medical coproation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT05730881
Other Study ID Numbers:
  • MRC-01-22-701
First Posted:
Feb 16, 2023
Last Update Posted:
Feb 16, 2023
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2023