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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Poor neurological outcome evaluated using the CPC score [Срок оценки: At day-28]

Вторичные конечные точки (3)

• Net reclassification index [Срок оценки: At day-28]
• Brain death [Срок оценки: At day-28]
• Days without limitation of life sustaining treatment [Срок оценки: At day-28]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 5 центров

• Brest University Hospital — Brest
• Nantes University Hospital — Nantes
• Marseille University Hospital — Marseille
• Ambroise Paré - Hartmann Private Hospital Group — Neuilly-sur-Seine
• Cochin Hospital — Paris

Идентификаторы

NCT: NCT06044922 · 2022/01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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