Health TrialsbyHealthPanel

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

ConditionCardiac Arrest
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCMC Ambroise Paré

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Comatose patients admitted in ICU after resuscitation from cardiac arrest

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 24-hour Holter monitoring

    Device

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Post-cardiac arrest patients1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At day-28

Secondary outcomes

1

Net reclassification index

Time frame
At day-28
2

Brain death

Time frame
At day-28
3

Days without limitation of life sustaining treatment

Time frame
At day-28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CMC Ambroise Paré

Lead sponsor

Source ClinicalTrials.gov
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