Actively Recruiting

Age: 18Years +
All Genders
NCT06044922

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

Led by CMC Ambroise Paré · Updated on 2024-12-16

200

Participants Needed

5

Research Sites

164 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted in intensive care unit (ICU) after resuscitation from cardiac arrest (in-hospital or out-of-hospital)
  • Coma with Glasgow score less than 8 after return of spontaneous circulation (ROSC)
  • Requires sedation and targeted temperature management for at least 24 hours
Not Eligible

You will not qualify if you...

  • Patient with limitation of life support techniques at ICU admission (dying patient)
  • Presence of non-sinus heart rhythm
  • Pregnant or breastfeeding women
  • Patient under legal protection (guardianship, curators, or safeguard of justice)
  • Opposition by trusted person or patient upon waking

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Brest University Hospital

Brest, Brittany Region, France, 29609

Actively Recruiting

2

Nantes University Hospital

Nantes, Pays de la Loire Region, France, 44093

Actively Recruiting

3

Marseille University Hospital

Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005

Actively Recruiting

4

Ambroise Paré - Hartmann Private Hospital Group

Neuilly-sur-Seine, Île-de-France Region, France, 92200

Actively Recruiting

5

Cochin Hospital

Paris, Île-de-France Region, France, 75014

Actively Recruiting

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Research Team

G

Guillaume GERI, MD, PhD

CONTACT

C

Cécile NAUDIN, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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