Clinical trial NCT03806660: Early DiaGnosis of Anoxic Brain Injury for Resuscitated Patients
Official title: Evaluation of Early Prognosis Factors of Neurological Evolution After Resuscitated Cardiac Arrest in Adults
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Cardiac Arrest
Keywords: Cardiac Arrest
Coma
hypoxic brain damage
prognosis
neurological examination
pupillary reflex
electroencephalography
targeted temperature management
biomarkers
clinical score
evoked potentials
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every major patient admitted in the Mercy Hospital CHR Metz-Thionville intensive care unit after CA

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.

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.

Eligibility criteria: Inclusion Criteria:

* Admission in Intensive Care Unit (ICU) following cardiac arrest with ROSC

Exclusion Criteria:

* Minor patient
* Cardiac arrest (CA) occuring in ICU
* Decision before ICU admission to withdraw life-sustaining treatments
* Patient with post-ROSC Glasgow Coma Score = 15

Primary outcomes:
measure: Cerebral Performance Categories (CPC) score
timeFrame: Day 1
Secondary outcomes:
measure: Cardiac Arrest Hospital Prognosis (CAHP) Score
timeFrame: Day 1
measure: Pupillary light reflex surveillance with automated infrared pupillometry
timeFrame: Day 1
measure: Neuron Specific Enolase (NSE) plasmatic levels
timeFrame: Day 2
measure: Neuron Specific Enolase (NSE) plasmatic levels
timeFrame: Day 3
measure: Amplitude-integrated electroencephalography (aEEG)
timeFrame: Day 1
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville
Study officials:
References: