- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03806660
Early DiaGnosis of Anoxic Brain Injury for Resuscitated Patients (EDGAR)
Evaluation of Early Prognosis Factors of Neurological Evolution After Resuscitated Cardiac Arrest in Adults
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rostane GACI, MD
- Phone Number: 0033 387186220
- Email: r.gaci@chr-metz-thionville.fr
Study Contact Backup
- Name: Serge Le Tacon, MD
- Phone Number: 0033 387186235
- Email: s.le-tacon@chr-metz-thionville.fr
Study Locations
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Metz, France, 57085
- CHR Metz Thionville
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral Performance Categories (CPC) score
Time Frame: 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).
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Arrest Hospital Prognosis (CAHP) Score
Time Frame: Day 1
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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)
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Day 1
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Pupillary light reflex surveillance with automated infrared pupillometry
Time Frame: Day 1
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Bilateral testing by trained nurse (3 measures, best result between the 2 eyes considered)
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Day 1
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Neuron Specific Enolase (NSE) plasmatic levels
Time Frame: Day 2
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Neuron Specific Enolase (NSE) plasmatic levels (ng/ml)
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Day 2
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Neuron Specific Enolase (NSE) plasmatic levels
Time Frame: Day 3
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Neuron Specific Enolase (NSE) plasmatic levels (ng/ml)
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Day 3
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Amplitude-integrated electroencephalography (aEEG)
Time Frame: Day 1
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Amplitude-integrated electroencephalography (aEEG) with Hellstrom-Westas classification
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Day 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-06Obs-CHRMT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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