Cardiac ArrestEDGARNCT03806660
Early DiaGnosis of Anoxic Brain Injury for Resuscitated Patients
An observational study of Cardiac Arrest, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 1 Sep 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every major patient admitted in the Mercy Hospital CHR Metz-Thionville intensive care unit after CA
Who may be able to join
- Admission in Intensive Care Unit (ICU) following cardiac arrest with ROSC
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Early Prognosis Factors of Neurological Evolution After Resuscitated Cardiac Arrest in Adults
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.
Read the 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.
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac Arrest, Coma, hypoxic brain damage, prognosis, neurological examination, pupillary reflex, electroencephalography, targeted temperature management, biomarkers, clinical score, evoked potentials
- Medical subject headings
- Heart Arrest, Coma, Hypoxia, Brain
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Performance Categories (CPC) score
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).
Measured: Day 1
Secondary outcomes (5)
Cardiac Arrest Hospital Prognosis (CAHP) Score
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)
Measured: Day 1
Pupillary light reflex surveillance with automated infrared pupillometry
Bilateral testing by trained nurse (3 measures, best result between the 2 eyes considered)
Measured: Day 1
Neuron Specific Enolase (NSE) plasmatic levels
Neuron Specific Enolase (NSE) plasmatic levels (ng/ml)
Measured: Day 2
Neuron Specific Enolase (NSE) plasmatic levels
Neuron Specific Enolase (NSE) plasmatic levels (ng/ml)
Measured: Day 3
Amplitude-integrated electroencephalography (aEEG)
Amplitude-integrated electroencephalography (aEEG) with Hellstrom-Westas classification
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Sep 2018
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Why it stopped: lack of staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806660
- Sponsor's protocol ID
- 2018-06Obs-CHRMT
- Acronym
- EDGAR
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2018
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Early Prognosis Factors of Neurological Evolution After Resuscitated Cardiac Arrest in Adults
- ClinicalTrials.gov ID
- NCT03806660
- Acronym / sponsor ID
- EDGAR / 2018-06Obs-CHRMT
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac Arrest, Coma, hypoxic brain damage, prognosis, neurological examination, pupillary reflex, electroencephalography, targeted temperature management
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: lack of staff
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every major patient admitted in the Mercy Hospital CHR Metz-Thionville intensive care unit after CA
Key inclusion criteria (1 listed)
- Admission in Intensive Care Unit (ICU) following cardiac arrest with ROSC
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
5 secondary outcomes
Cardiac Arrest Hospital Prognosis (CAHP) Score
Time frame: Day 1
Pupillary light reflex surveillance with automated infrared pupillometry
Time frame: Day 1
Neuron Specific Enolase (NSE) plasmatic levels
Time frame: Day 2
Neuron Specific Enolase (NSE) plasmatic levels
Time frame: Day 3
Amplitude-integrated electroencephalography (aEEG)
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Performance Categories (CPC) score (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.