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

Qatar200 participantsStarted 2023-03-30

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* Inclusion criteria * Age more than18 years old. * Patients undergoing institution of VA ECMO * Exclusion criteria * Patients staying \< 12 hours in the ICU

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing four different scoring systems to predict who survives on VA-ECMO for cardiogenic shock — can you explain what those scores are and whether any of them are already being used to guide decisions in my care?
2Since this study is observational and focused on predicting survival rather than testing a new treatment, does participating in it change anything about the actual care I would receive, or is it purely about tracking outcomes?
3The recruitment status for this trial is listed as unknown — do you know whether this study is still actively enrolling patients at this center, and if so, what would my involvement actually look like day to day?
4Given that my situation involves cardiogenic shock and possibly VA-ECMO support, how do these predictive scoring tools factor into the decisions your team is already making about my treatment plan?
5Are there standard-of-care pathways or other active treatment trials for cardiogenic shock that might be worth exploring alongside or instead of participating in this observational study?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survival predictive accuracy of four scores

Timeframe: 6 months

Trial details

NCT IDNCT05730881

SponsorHamad Medical Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-09-30

Contact for this trial

Suraj Sudarsanan, MD

44395897 Sudarsanan@hamad.qa

View on ClinicalTrials.gov More Cardiogenic Shock trials