Predictive Outcome in Comatose Patients
Recruiting now
Conditions studied: Coma, Heart Arrest, Cardiopulmonary Resuscitation
In brief
Evaluating the prognosis of comatose patients after cardiac arrest (CA) in the intensive care unit (ICU) remains challenging. It requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations, (among them auditive evoked potentials or AEP) but none has a sufficient sensitivity/specificity. In a preliminary study, the investigators developed an algorithm from the signal collected with AEP, and generated a probability map to visually classify the participants after the algorithm processing. Participants could be classified either with a good neurological prognosis or with bad neurological prognosis or death. The investigators hypothesize that the "PRECOM" tool, applied blindly to a large prospective multicenter cohort of patients admitted to intensive care for coma in the aftermath of CA will predict neurological prognosis at 3 months with high sensitivity and specificity.
Key facts
- Study ID
- NCT05321459
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 100
- Starts
- 2023-11-15
- Expected to finish
- 2028-05-29
- Last updated by the study team
- 2025-12-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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 is running
- APHP Cochin Hospital - médecine intensive-réanimation — Paris, France (enrolling)
- Delafontaine Hospital - médecine intensive-réanimation — Saint-Denis, France (enrolling)
- APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique — Paris, France (enrolling)
- APHP Avicenne Hospital - Réanimation médico-chirurgicale — Bobigny, France (enrolling)
- APHP HEGP hospital - Réanimation médicale — Paris, France (enrolling)
- APHP Bichat Hospital -Médecine intensive - réanimation infectieuse — Paris, France (enrolling)
- APHP Lariboisière Hospital, Clinical Physiology Department — Paris, France
Full record on ClinicalTrials.gov
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