Status:
RECRUITING
Predictive Outcome in Comatose Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ecole Normale Supérieure de Paris
Conditions:
Coma
Heart Arrest
Eligibility:
All Genders
18+ years
Brief Summary
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 examinat...
Detailed Description
Evaluating the prognosis of comatose participants after cardiac arrest (CA) in the intensive care unit remains challenging. It requires a multimodal approach combining standardized clinical examinatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 29 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05321459
Start Date
November 15 2023
End Date
May 29 2028
Last Update
December 23 2025
Active Locations (7)
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1
APHP Avicenne Hospital - Réanimation médico-chirurgicale
Bobigny, France, 93000
2
APHP Lariboisière Hospital, Clinical Physiology Department
Paris, France, 75010
3
APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique
Paris, France, 75010
4
APHP Cochin Hospital - médecine intensive-réanimation
Paris, France, 75014