Clinical trial NCT06044922: Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest
Official title: Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Keywords: Heart rate variability
Neurologic prognosis
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Comatose patients admitted in ICU after resuscitation from cardiac arrest

Brief 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 criteria: 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 outcomes:
measure: Poor neurological outcome evaluated using the CPC score
timeFrame: At day-28
Secondary outcomes:
measure: Net reclassification index
timeFrame: At day-28
measure: Brain death
timeFrame: At day-28
measure: Days without limitation of life sustaining treatment
timeFrame: At day-28
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
state: Bretagne
city: Neuilly-sur-Seine
country: France
facility: Ambroise Paré - Hartmann Private Hospital Group
state: Ile-de-France
city: Paris
country: France
facility: Cochin Hospital
state: Ile-de-France
city: Nantes
country: France
facility: Nantes University Hospital
state: Pays de la Loire
city: Marseille
country: France
facility: Marseille University Hospital
state: Provence-Alpes-Côte d'Azur
Study officials:
References: