Predicting outcomes for comatose patients after cardiac arrest
Official title: New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit
Run by Assistance Publique - Hôpitaux de Paris · NCT05321459 · Data updated 2026-11-12
This study is trying to see if a new method can help doctors predict how well comatose patients will recover after a cardiac arrest by using different tests and a special algorithm.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 7 sites (Bobigny and 6 other locations) |
| Status | Recruiting |
| Started | November 15, 2023 |
| Main results expected | March 1, 2028 |
| Study ends | May 29, 2028 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT05321459 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who are admitted to the ICU for coma following cardiac arrest and show persistent coma on day 3.
✕Probably not a fit
Patients who have a decision to limit resuscitation therapies or those unable to undergo auditory evoked potentials due to specific conditions will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the prognosis of comatose patients following cardiac arrest in the intensive care unit using a multimodal approach. It combines clinical examinations, serum biomarkers, imaging, and electrophysiological tests, including auditory evoked potentials (AEP). A novel algorithm developed from AEP signals generates a probability map to classify patients' neurological prognosis as either good or bad. The goal is to apply this algorithm to a large cohort of patients to improve the accuracy of prognosis predictions at three months post-event.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the ability to predict neurological outcomes in comatose patients, leading to better-informed treatment decisions.
How similar studies have gone: Preliminary studies have shown promise in using similar multimodal approaches for prognosis prediction, but this specific algorithm application is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age above18 years old * Patient affiliated to a French Heath Care Insurance * Admitted in the intensive care unit (ICU) for coma post extra- or intra-hospital cardiac arrest (CA) with shockable or non-shockable rhythm * Persistent coma on day 3 after post CA, defined by the inability to respond to a verbal command in an appropriate manner (motor Glasgow components ≤ 3) and at the time of neurophysiological recordings (D3-D7 ± week -end). Exclusion Criteria: * Decision to limit resuscitation therapies taken by the resuscitation team * Inability to perform the auditory evoked potentials (AEP) (deafness, skin lesion or any condition preventing to record AEP). * Opposition by the trusted person or by the patient once he/she wakes up
Where it's running
-
APHP Avicenne Hospital - Réanimation médico-chirurgicale
Bobigny, France Recruiting -
APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique
Paris, France Recruiting -
APHP Cochin Hospital - médecine intensive-réanimation
Paris, France Recruiting -
APHP HEGP hospital - Réanimation médicale
Paris, France Recruiting -
APHP Bichat Hospital -Médecine intensive - réanimation infectieuse
Paris, France Recruiting -
Delafontaine Hospital - médecine intensive-réanimation
Saint-Denis, France Recruiting
Show 1 more location
-
APHP Lariboisière Hospital, Clinical Physiology Department
Paris, France Active not recruiting
Study contacts
- Study coordinator: Nathalie KUBIS, Md, PhD
- Email: nathalie.kubis@aphp.fr
- Phone: +33(0)149958324
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.