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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: 24-hour Holter monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-cardiac arrest patients<br> | Device: 24-hour Holter monitoring<br>* Holter monitor is fitted within 2h of ICU admission to acquire a 24-hour electrocardiogram recording<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Poor neurological outcome evaluated using the CPC score | The CPC (Cerebral Performance Category) score assesses neurological status after cardiac arrest on a scale of 1 to 5 (1 = conscious and normal; 2 = conscious with moderate disability; 3 = conscious with severe disability; 4 = coma or vegetative state; 5 = death). The CPC score will be dichotomized as follow: good neurological outcome for categories 1 and 2 and poor neurological outcome or death for categories 3, 4 and 5. The CPC score will be obtained at day-28 from an in-hospital visit if the patient is still hospitalized or by phone call if patient returned home. | At day-28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net reclassification index |  | At day-28 | 
| Brain death |  | At day-28 | 
| Days without limitation of life sustaining treatment |  | At day-28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart rate variability, Neurologic prognosis