Early and Objective Assessment of Neurological Prognosis in Cardiac Arrest Patients

NCT06387225 | Recruiting

• 1 other identifier: RC23_0248
• Study Type: observational
• Target: 608
• Locations: 1 country
• Sites: 4

Brief Summary

Cerebral lesions are responsible for two thirds of deaths in patients admitted to intensive care following cardiac arrest. Patients with neurological lesions should be the priority target for neuroprotective interventions, which are the cornerstone of post-cardiac arrest care (allowing a reduction in the burden of care for patients without this type of lesion). Furthermore, these interventions must be based on a precise assessment of the severity of these brain lesions: carrying out neuro-protective interventions in patients without brain lesions exposes these patients to unnecessary treatment potentially associated with adverse effects without any possible benefit. However, the early assessment of neurological prognosis, particularly on admission to intensive care, is an area where there is little research and where it is not possible to obtain a precise and reproducible assessment. Several tools can be used to assess this prognosis at an early stage: anamnesis and characteristics of the cardiac arrest and the patient's comorbidities, imaging, electrophysiology and biomarkers. To assess the predictive value of early biomarker testing in patients resuscitated after cardiac arrest, whatever the cause, the investigators plan to conduct a prospective observational multicentre trial. It is important to bear in mind that the aim of this study is not to assess the long-term prognosis of patients suffering cardiac arrest in order to take measures to limit or discontinue active therapies, but simply to provide a reliable tool, simple and quick to use, in order to be able to identify a sub-population of patients who should be the subject of preferential neuro-protection measures, and conversely to simplify management (moderate temperature control, early cessation of sedation, early extubation) for patients with no neurological lesions.

Conditions

Cardiac Arrest; Neurologic Symptoms; Intensive Care Neurological Disorder

Outcome Measures

Primary Outcomes (3)

• Dosage of biomarker UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care

  Determine an assay threshold value admission to the intensive care unit to predict membership of a homogeneous group with favorable neurological outcome at D90

  at ICU admission

• Dosage of biomarker GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care

  Determine an assay threshold value admission to the intensive care unit to predict membership of a homogeneous group with favorable neurological outcome at D90

  at ICU admission

• Neurological outcome at D90 assessed by modified Rankin scale (mRS)

  Determine an assay threshold value admission to the intensive care unit to predict membership of a homogeneous group with favorable neurological outcome at D90

  90 days after patient enrolment in the study

Secondary Outcomes (5)

• Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care

  at ICU admission

• Dosage of biomarkers GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care

  at ICU admission

• Dosage of biomarkers UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at 4 hours for recovery of effective cardiac activity (RACS)

  at 4 hours for recovery of effective cardiac activity (RACS)

• Dosage of biomarkers GFAP( Glial fibrillary acidic protein) at 4 hours for recovery of effective cardiac activity (RACS)

  at 4 hours for recovery of effective cardiac activity (RACS)

• Neurological outcome at D90 assessed by modified Rankin scale (mRS) ranging from 0 to 6

  90 days after patient enrolment in the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be included on admission to intensive care.

You may qualify if:

• Age ≥ 18 years
• Admitted to intensive care with out-of-hospital cardiac arrest
• Comatose on admission (defined by a Glasgow score ≤ 8)

You may not qualify if:

• In-hospital cardiac arrest
• Age \< 18 years
• Person under guardianship or legal protection

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (4)

CHD Vendée

La Roche-sur-Yon, 85025, France

RECRUITING

CHU Nantes

Nantes, 44093, France

RECRUITING

APHP - Hôpital Cochin

Paris, 75679, France

RECRUITING

CH Saint-Nazaire

Saint-Nazaire, 44600, France

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jean-Baptiste LASCARROU

CONTACT

0240087386; jeanbaptiste.lascarrou@chu-nantes.fr

Study Design

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

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 26, 2024
• Study Start: February 2, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

FR (4)