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Clinical Trials in France / NCT06044922
Recruiting Observational

Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest

NCT06044922 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-10-23
Last updated
2024-12-16

Condition(s) studied

Cardiac Arrest

Investigational drug(s) / intervention(s)

24-hour Holter monitoring

24-hour Holter monitoring: Holter monitor is fitted within 2h of ICU admission to acquire a 24-hour electrocardiogram recording

Study summary

Despite advances in post-resuscitation care of patients with cardiac arrest (CA), the majority of survivors who are treated after restoration of spontaneous circulation (ROSC) will have sequelae of hypoxic-ischemic brain injury ranging from mild cognitive impairment to a vegetative state.

Early prognostication in comatose patients after ROSC remains challenging. Recent recommendations suggest carrying out clinical and paraclinical tests during the first 72 h after ROSC, to predict a poor neurological outcome with a specificity greater than 95% (no pupillary and corneal reflexes, bilaterally absent N20 somatosensory evoked potential wave, status myoclonus, highly malignant electroencephalography including suppressed background ± periodic discharges or burst-suppression, neuron-specific enolase (NSE) \> 60 µg/L, a diffuse and extensive anoxic injury on brain CT/MRI), but with a low sensitivity due to frequent confounding factors.

The heart rate variability (HRV) is a simple and non-invasive technique for assessing the autonomic nervous system function. In patients with a recent myocardial infarction, reduced HRV is associated with an increased risk for malignant arrhythmias or death. In neurology, reduced HRV is associated with a poor outcome in severe brain injury patients and allows to predict early neurological deterioration and recurrent ischemic stroke after acute ischemic stroke.

A reduced HRV could be a sensitive, specific and early indicator of diffuse anoxic brain injury after CA.

This multicenter prospective cohort study assesses the added value of early HRV (within 24h of ICU admission) for neuroprognostication after cardiac arrest.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Admitted in intensive care unit (ICU) after resuscitation from cardiac arrest (in-hospital or out-of-hospital) * Coma (Glasgow score \< 8) after ROSC, requiring sedation and targeted temperature management for at least 24h Exclusion Criteria: * Dying patient (Limitation of life support techniques at admission to the ICU) * Non-Sinus Rhythm * Pregnant or breastfeeding women * Patient under protection of the adults (guardianship, curators or safeguard of justice) * Opposition by the trusted person or by the patient once he/she wakes up

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Brest University Hospital Brest Brittany Region Recruiting
Nantes University Hospital Nantes Pays de la Loire Region Recruiting
Marseille University Hospital Marseille Provence-Alpes-Côte d'Azur Region Recruiting
Ambroise Paré - Hartmann Private Hospital Group Neuilly-sur-Seine Île-de-France Region Recruiting
Cochin Hospital Paris Île-de-France Region Recruiting

More CMC Ambroise Paré trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06044922 on ClinicalTrials.gov ↗ ← All trials in France