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Early DiaGnosis of Anoxic Brain Injury for Resuscitated Patients (EDGAR)

C

Centre Hospitalier Régional Metz-Thionville

Status

Suspended

Conditions

Cardiac Arrest

Study type

Observational

Funder types

Other

Identifiers

NCT03806660
2018-06Obs-CHRMT

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Rostane GACI, MD; Serge Le Tacon, MD

Data sourced from clinicaltrials.gov

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