EDGAR: Early DiaGnosis of Anoxic Brain Injury for Resuscitated Patients

Sponsor

Centre Hospitalier Régional Metz-Thionville (Other)

Overall Status

Recruiting

CT.gov ID

NCT03806660

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sudden cardiac arrest (CA) in adults remains a major public health issue in industrialized countries, leading to a mortality rate greater than 90%. The analysis of French data estimates the number of sudden deaths at around 40,000 per year. The incidence rate for non-hospital CAs is 55 per 100,000 every year with an immediate survival rate of 9% and 4.8% at one year.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest

Detailed Description

Approximately 80 % of patients who survive CA with cardiopulmonary resuscitation are comatose. The longer it lasts, the lower chances of recovery. The evaluation of the neurological prognosis of these patients is an important issue. Indeed, 72% of patients admitted to an intensive care unit after resuscitation from CA will give rise to an ethical discussion with the family. The prognostication strategy is usually based on a multimodal process involving clinical examination, electro-neurophysiological and biological examinations. We plan to study the relevance of early neurological prognostic tests in the aftermath of CA and in particular the most recent techniques such as the use of a clinical score (CAHP for Cardiac Arrest Hospital Prognosis), automated infrared pupillometry (NEUROLIGHT ALGISCAN, IDMED) for pupillary reflex measurement and quantitative analysis of the continuous amplitude-integrated electroencephalogram (aEEG) BRAIN QUICK ICU LINE, MICROMED. These new prognostic criteria for CA (CAHP score, pupillometry and aEEG) developed separately have not yet been integrated into a multimodal strategy.

The goal of this study is to evaluate the performance of CAHP score, infrared automated pupillometry and aEEG to predict as early as 24h from ROSC the neurological prognosis (Cerebral Performance Categories) at hospital discharge.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Early Prognosis Factors of Neurological Evolution After Resuscitated Cardiac Arrest in Adults

Actual Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Outcome Measures

Primary Outcome Measures

Cerebral Performance Categories (CPC) score [Day 1]
The Cerebral Performance Categories (CPC) score is evaluated by a physician at hospital discharge (CPC baseline assessed on basal statut before CA). Good neurological outcome defined as CPC <3. CPC 1: no or minor disability (conscious and independent, able to work and lead a normal life. May have mild dysphasia, non-incapacitating hemiparesis, or minor cranial nerve abnormalities). CPC 2: Moderate disability (Conscious and independent, able to travel by public transport and work in sheltered environment, independent in activities of daily life. May have hemiplegia, seizures, ataxia, dysarthria or memory changes). Poor neurological outcome defined as CPC 3-5. CPC 3: severe disability (conscious but dependent, limited cognition, dementia, locked-in, minimally conscious. Usually in institution, but sometimes looked after at home with exceptional family effort). CPC 4: unconscious (persistent vegetative state). CPC 5: dead (certified brain dead or traditional criteria).

Secondary Outcome Measures

Cardiac Arrest Hospital Prognosis (CAHP) Score [Day 1]
Seven variables independently associated with poor neurological outcome (age, non-shockable rythm, time from collapse to basic life support, time from basic life support to return of spontaneous circulation, location of cardiac arrest, epinephrine dose and arterial pH)
Pupillary light reflex surveillance with automated infrared pupillometry [Day 1]
Bilateral testing by trained nurse (3 measures, best result between the 2 eyes considered)
Neuron Specific Enolase (NSE) plasmatic levels [Day 2]
Neuron Specific Enolase (NSE) plasmatic levels (ng/ml)
Neuron Specific Enolase (NSE) plasmatic levels [Day 3]
Neuron Specific Enolase (NSE) plasmatic levels (ng/ml)
Amplitude-integrated electroencephalography (aEEG) [Day 1]
Amplitude-integrated electroencephalography (aEEG) with Hellstrom-Westas classification