Clinical trial NCT05606809: Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Cardiac Arrest
Official title: Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Keywords: cardiac arrest
intensive care unit
mechanical ventilation
Lead sponsor: AfterROSC
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is an observational, prospective, multicentric prognostic study. The study period is 3 years, and investigators plan to include 4500 patients in 20 ICUs in France.

For all patients included, medical history, clinical data, paraclinical results and outcome (at hospital discharge and at 3 months, including modified Rankin score) will be prospectively collected by local investigator, according to an electronical CRF.

Brief summary: Even in patients with successful return of spontaneous circulation (ROSC), outcome after cardiac arrest remains poor. The overall in-hospital survival rate widely varies both worldwide and across communities, from 1 to 4 folds according to circumstances of arrest and post-resuscitation interventions. Several studies have already shown that early interventions performed after ROSC, such as treatment of the cause, targeted temperature management, optimal hemodynamic management and extra-corporeal life support in selected patients, could improve the outcome in post-cardiac arrest patients. However, the decision process regarding the allocation of these resources, in parallel with the management of patients' proxies, remains a complex challenge for physicians facing these situations. Consequently, several prediction models and scores have been developed in order to stratify the risk of unfavorable outcome and to discriminate the best candidates for post-resuscitation interventions. Overall, several scores exist, but external validation are lacking and direct comparisons are needed to assess relative interest of scoring systems. Indeed, establishing the optimal scoring system is crucial, for optimal treatment allocation and appropriate information to relatives.


Eligibility criteria: Inclusion Criteria:

* all adult patients, major, admitted to intensive care after cardiac arrest (after both in and out-of hospital cardiac arrest),
* comatose (defined by Glasgow score ≤ 8) on admission,

Exclusion Criteria:

* cardiac arrest occurring intra-hospital,
* minor patient,
* major patient under guardianship,
* protected persons,
* prior inclusion in the study

Primary outcomes:
measure: Determination of Area Under Curve of Cerebral Admission Hospital Prognosis (CAHP) Score at intensive care unit admission
timeFrame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
state: Pays De Loire
city: Massy
country: France
facility: Hopital Jacques Cartier
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Paré
city: Paris
country: France
facility: APHP, Cochin
city: Versailles
country: France
facility: CH Versailles
Study officials:
References: