Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Out of Hospital Cardiac Arrest

Completed

• Conditions: Cardiac Arrest
• Interventions: Diagnostic Test: Calculation of early prognosis score

• Registration Number: NCT04167891
• Lead Sponsor: AfterROSC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-19
• Study Start: 2020-08-01
• Primary Completion: 2022-06-30
• Status Verified: 2023-09
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 907

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients admitted in the intensive care unit	Calculation of early prognosis score	Patients with return of spontaneous circulation after cardiac arrest regardless of initial rhythm, and admitted in intensive care unit for post cardiac arrest care

Primary Outcome Measures

Name	Time	Method
Determination of Area Under Curve of Cerebral Admission Hospital Prognosis (CAHP) Score at intensive care unit admission	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)	Determination of AUC for CAHP score as compare to Utstein style criteria.; CAHP score range from 0 to 300 with higher score indicates poorer prognosis

Secondary Outcome Measures

Name	Time	Method
Determination of Area Under Curve of OHCA Score at intensive care unit admission	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)	Determination of AUC for OHCA score as compare to Utstein style criteria; OHCA score range from -30 to 60 with higher score indicates poorer prognosis
Determination of calibration of each score	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)	Determination of calibration of: CAHP, sCAHP, mCAHP, OHCA, CREST, C-Graph, TTM and NULL-PLEASE score
Determination of Area Under Curve of modified CAHP Score at intensive care unit admission	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)	Determination of AUC for modified CAHP score as compare to Utstein style criteria; mCAHP score range from 0 to 280 with higher score indicates poorer prognosis
Determination of Area Under Curve of NULL-PLEASE Score at intensive care unit admission	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)	Determination of AUC for NULL-PLEASE score as compare to Utstein style criteria; NULL-PLEASE score range from 0 to 14 with higher score indicates poorer prognosis
Determination of Area Under Curve of CREST Score at intensive care unit admission	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)	Determination of AUC for CREST score as compare to Utstein style criteria; CREST score range from 0 to 5 with higher score indicates poorer prognosis
Determination of Area Under Curve of C-Graph Score at intensive care unit admission	Intensive Care Unit Admission	Determination of AUC for C-Graph score as compare to Utstein style criteria; C-Graph score range from 0 to 5 with higher score indicates poorer prognosis
Determination of Area Under Curve of simplified CAHP Score at intensive care unit admission	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)	Determination of AUC for simplified CAHP score as compare to Utstein style criteria; sCAHP score range from 0 to 150 with higher score indicates poorer prognosis
Determination of Area Under Curve of TTM Score at intensive care unit admission	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)	Determination of AUC for TTM score as compare to Utstein style criteria; TTM score range from -2 to 35 with higher score indicates poorer prognosis

Trial Locations

Locations (27)

ERASME; 🇧🇪 Bruxelles, Belgium

CHU Angers; 🇫🇷 Angers, France

CHU Amiens; 🇫🇷 Amiens, France

CH Brive La Gaillard; 🇫🇷 Brive-la-Gaillarde, France

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France

CHU Ambroise Paré; 🇫🇷 Boulogne-Billancourt, France

CH Bethune; 🇫🇷 Béthune, France

CH Cherbourg en Cotentin; 🇫🇷 Cherbourg, France

CHU Créteil; 🇫🇷 Créteil, France

CH La Rochelle; 🇫🇷 La Rochelle, France

CH Versailles; 🇫🇷 Le Chesnay, France

CH Le Mans; 🇫🇷 Le Mans, France

Hospices Civils Lyon; 🇫🇷 Lyon, France

CHU Lille; 🇫🇷 Lille, France

Hopital Privé Jacques Cartier; 🇫🇷 Massy, France

APHM; 🇫🇷 Marseille, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHRU Nancy; 🇫🇷 Nancy, France

CHU Nantes; 🇫🇷 Nantes, France

APHP, CHU Saint Louis; 🇫🇷 Paris, France

APHP, CHU Necker; 🇫🇷 Paris, France

GHP Saint Joseph; 🇫🇷 Paris, France

CHU Cochin; 🇫🇷 Paris, France

Aphp, Hegp; 🇫🇷 Paris, France

CHU Lariboisière; 🇫🇷 Paris, France

CH Toulon; 🇫🇷 Toulon, France

Clinique Privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, France