NCT05606809

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Nov 2022Dec 2027

First Submitted

Initial submission to the registry

October 31, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

4.9 years

First QC Date

October 31, 2022

Last Update Submit

September 30, 2025

Conditions

Keywords

cardiac arrestintensive care unitmechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Determination of Area Under Curve of Cerebral Admission Hospital Prognosis (CAHP) Score at intensive care unit admission

    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

    Intensive Care Unit Admission (Usually 3 hours after cardiac arrest

Interventions

Early prognosis score will be calculated at intensive care unit admission for each patient based on clinical and biological values as required

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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,

You may not qualify if:

  • cardiac arrest occurring intra-hospital,
  • minor patient,
  • major patient under guardianship,
  • protected persons,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Nantes

Nantes, Pays de Loire, France

RECRUITING

Hopital Jacques Cartier

Massy, France

RECRUITING

Clinique Ambroise Paré

Neuilly-sur-Seine, France

RECRUITING

APHP, Cochin

Paris, France

RECRUITING

CH Versailles

Versailles, France

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Jean Baptiste Lascarrou, MD, PhD

CONTACT

Alain Cariou, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 7, 2022

Study Start

November 2, 2022

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

October 3, 2025

Record last verified: 2025-09

Locations