Clinical trial NCT04167891: Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Out of Hospital Cardiac Arrest
Official title: Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Out of Hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: cardiac arrest
hypothermia induced
intensive care unit
Lead sponsor: AfterROSC
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 1144
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 1 year, and we plan to include 597 patients in 21 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 out-of-hospital cardiac arrest and 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:
measure: Determination of Area Under Curve of modified CAHP Score at intensive care unit admission
timeFrame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
measure: Determination of Area Under Curve of simplified CAHP Score at intensive care unit admission
timeFrame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
measure: Determination of Area Under Curve of OHCA Score at intensive care unit admission
timeFrame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
measure: Determination of Area Under Curve of CREST Score at intensive care unit admission
timeFrame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
measure: Determination of Area Under Curve of C-Graph Score at intensive care unit admission
timeFrame: Intensive Care Unit Admission
measure: Determination of Area Under Curve of TTM Score at intensive care unit admission
timeFrame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
measure: Determination of Area Under Curve of NULL-PLEASE Score at intensive care unit admission
timeFrame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
measure: Determination of calibration of each score
timeFrame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: ERASME
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU Angers
city: Boulogne-Billancourt
country: France
facility: CHU Ambroise Paré
city: Brive-la-Gaillarde
country: France
facility: CH Brive La Gaillard
city: Béthune
country: France
facility: CH Bethune
city: Cherbourg
country: France
facility: CH Cherbourg en Cotentin
city: Créteil
country: France
facility: CHU Créteil
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: La Rochelle
country: France
facility: CH La Rochelle
city: Le Chesnay
country: France
facility: CH Versailles
city: Le Mans
country: France
facility: CH Le Mans
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: Hospices Civils Lyon
city: Marseille
country: France
facility: APHM
city: Massy
country: France
facility: Hopital Privé Jacques Cartier
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHRU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: APHP, CHU Necker
city: Paris
country: France
facility: APHP, CHU Saint Louis
city: Paris
country: France
facility: Aphp, Hegp
city: Paris
country: France
facility: CHU Cochin
city: Paris
country: France
facility: CHU Lariboisière
city: Paris
country: France
facility: GHP Saint Joseph
city: Quincy-sous-Sénart
country: France
facility: Clinique Privé Claude Galien
city: Toulon
country: France
facility: CH Toulon
Study officials:
affiliation: AfterROSC
name: Alain Cariou, MD, PhD
role: STUDY_CHAIR
References: