Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 24-hour Holter monitoring.
- Who it may be relevant to
- Registry conditions: Cardiac Arrest. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 24-hour Holter monitoring
Holter monitor is fitted within 2h of ICU admission to acquire a 24-hour electrocardiogram recording
Primary outcome measures
- Poor neurological outcome evaluated using the CPC score [Time frame: At day-28]
Secondary outcome measures (3)
- Net reclassification index [Time frame: At day-28]
- Brain death [Time frame: At day-28]
- Days without limitation of life sustaining treatment [Time frame: At day-28]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 5 centers
- Brest University Hospital — Brest
- Nantes University Hospital — Nantes
- Marseille University Hospital — Marseille
- Ambroise Paré - Hartmann Private Hospital Group — Neuilly-sur-Seine
- Cochin Hospital — Paris
Identifiers
NCT: NCT06044922 · 2022/01