Early and Objective Assessment of Neurological Prognosis in Cardiac Arrest Patients

Cardiac Arrest Clinical Trial

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Official title:

Early and Objective Assessment of Neurological Prognosis in Cardiac Arrest Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06387225
• Other study ID #: RC23_0248
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: April 2024
• Source: Nantes University Hospital
• Contact: Jean-Baptiste LASCARROU
• Phone: 0240087386
• Email: jeanbaptiste.lascarrou[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 608
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Admitted to intensive care with out-of-hospital cardiac arrest
• Comatose on admission (defined by a Glasgow score = 8)
• Informed relative who has consented to the patient's participation in the study or inclusion under emergency procedure if the relative is absent at the time of inclusion

Exclusion Criteria:

• In-hospital cardiac arrest
• Age < 18 years
• Person under guardianship or legal protection
• Prior inclusion in the study

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Intensive Care Neurological Disorder
• Nervous System Diseases
• Neurologic Manifestations
• Neurologic Symptoms

Locations

Country	Name	City	State
France	CHD Vendée	La Roche-sur-Yon
France	APHP - Hôpital Cochin	Paris
France	CH Saint-Nazaire	Saint-Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care	Determine prognostic value (positive and negative predictive value (PPV/NPV), positive and negative likelihood ratio (LR+/LR-) of each biomarker separately according to the threshold on admission.; Determine the value of combining the two biomarkers at admission.	at ICU admission
Secondary	Dosage of biomarkers GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care	Determine prognostic value (positive and negative predictive value (PPV/NPV), positive and negative likelihood ratio (LR+/LR-) of each biomarker separately according to the threshold on admission.; Determine the value of combining the two biomarkers at admission.	at ICU admission
Secondary	Dosage of biomarkers UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at 4 hours for recovery of effective cardiac activity (RACS)	Determine a threshold value at H4 for recovery of effective cardiac activity (RACS) to predict membership of a homogeneous group with a favorable neurological outcome at D90.; Determine interest of combining the two biomarkers at H4 of the RACS.	at 4 hours for recovery of effective cardiac activity (RACS)
Secondary	Dosage of biomarkers GFAP( Glial fibrillary acidic protein) at 4 hours for recovery of effective cardiac activity (RACS)	Determine a threshold value at H4 for recovery of effective cardiac activity (RACS) to predict membership of a homogeneous group with a favorable neurological outcome at D90.; Determine interest of combining the two biomarkers at H4 of the RACS.	at 4 hours for recovery of effective cardiac activity (RACS)
Secondary	Neurological outcome at D90 assessed by modified Rankin scale (mRS) ranging from 0 to 6	Determine a threshold value at H4 for recovery of effective cardiac activity (RACS) to predict membership of a homogeneous group with a favorable neurological outcome at D90.; A score of 0 to 3 is considered a favorable neurological outcome.	90 days after patient enrolment in the study