Predicting outcomes for comatose patients after cardiac arrest
New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 7 sites (Bobigny and 6 other locations) |
| Trial ID | NCT05321459 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Preliminary studies have shown promise in using similar multimodal approaches for prognosis prediction, but this specific algorithm application is novel.
Eligibility criteria
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 this trial is running
Bobigny and 6 other locations
- APHP Avicenne Hospital - Réanimation médico-chirurgicale — Bobigny, France (Recruiting)
- APHP Lariboisière Hospital, Clinical Physiology Department — Paris, France (Active_not_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)
Study contacts
- Study coordinator: Nathalie KUBIS, Md, PhD
- Email: nathalie.kubis@aphp.fr
- Phone: +33(0)149958324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.