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Search / Trial NCT05321459

Predictive Outcome in Comatose Patients

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 4, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Post Cardiac Arrest For Comatose Patients Electroencephalography Somatosensory Evoked Potentials Auditory Evoked Potentials Prognosis Algorithms Classification

ClinConnect Summary

This clinical trial, titled "Predictive Outcome in Comatose Patients," is studying how to better predict the recovery of patients who are in a coma after a cardiac arrest. When someone has a cardiac arrest, they may need lifesaving procedures, and some may end up in a coma in the intensive care unit (ICU). The researchers are testing a new tool called "PRECOM," which uses data from a specific hearing test (called auditory evoked potentials, or AEP) to help classify patients based on their chances for recovery after three months. The goal is to provide more accurate predictions about whether patients will have a good or bad outcome.

To be eligible for this trial, participants need to be at least 18 years old and must have been admitted to the ICU for a coma following a cardiac arrest. They also need to show signs of persistent coma on the third day after the event. Certain patients may not be eligible, such as those who are not able to undergo the hearing test or if a medical team decides to limit their treatment. For those who join the study, they can expect to undergo the auditory test and be part of a larger group of patients being monitored to see how well this new prediction tool works. This trial is an important step in improving care for patients who have experienced a cardiac arrest and may help families understand what to expect in terms of recovery.

Gender

ALL

Eligibility 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

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Bobigny, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Saint Denis, , France

Patients applied

0 patients applied

Trial Officials

Nathalie KUBIS, Md,PhD

Study Director

APHP Lariboisière Hospital, Clinical Physiology Department

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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