Cardiac ArrestNCT02888184
Identification of Neurological Prognostic Markers of Cardiac Arrest Patients Alive on 3rd Day
An observational study of Cardiac Arrest, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The aim of the study is to identify prognostication predictors of 6-months neurological outcome in survivors at day 3 after cardiac arrest (CA) treated with therapeutic hypothermia (TH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Mar 2013
- 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: All adult patients (≥ 18 years) successfully resuscitated of out-of-hospital cardiac arrest (OHCA) and admitted to ICU.
Who may be able to join
- ≥ 18 years
- successfully resuscitated of out-of-hospital cardiac arrest (OHCA)
- patients admitted to ICU
Who cannot join
- in-hospital cardiac arrest patients
- death before ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuron Specific Enolase and Glasgow Motor Score Remain Useful Tools for Assessing Neurological Prognosis After Out-of-hospital Cardiac Arrest Treated With Therapeutic Hypothermia
The aim of the study is to identify prognostication predictors of 6-months neurological outcome in survivors at day 3 after cardiac arrest (CA) treated with therapeutic hypothermia (TH).
Read the detailed description
Cardiac arrest (CA) management remains challenging. As fewer than 20% of patients survive to discharge, early prognostication of functional outcome needs accurate prediction.Survivors outcome depends on initial CA conditions (cause, duration and severity of ischemic injury) that may lead to the post-cardiac arrest syndrome, associated with high mortality. Hypoxic-ischemic encephalopathy is the second cause of poor outcome after CA. Indeed, most survivors remain comatose or in a vegetative state leading to decisions to withdraw life support. Thus, the American Academy of Neurology had proposed a decision algorithm for use in prognostication of comatose survivors published in 2006.Before the widespread use of therapeutic hypothermia (TH), predictor factors of neurological outcome were: serum neuron-specific enolase (NSE), N20 somatosensory-evoked potentials (SSEP), status epilepticus, pupil and corneal reflexes and Glasgow coma score motor response (GCS-M). Therapeutic hypothermia is recommended in the management of CA.It has been associated with improved outcome after ventricular fibrillation out-of-hospital cardiac arrest (OHCA). However, TH may interfere with clinical examination and electrophysiological predictors (EEG, SSEP) making prognostication of functional outcome hardiest.The use of sedative drugs and muscle paralysis during TH is another cause of delayed neurological assessment and prognostication.The NSE cutoff values to predict poor neurological outcome are not well defined and can be influenced by TH either.The present study aims at identifying clinical, electrophysiological and biological prognostication predictors of 6-month neurological outcome in survivors at day 3 after CA treated by TH. Neurological functional status was assessed using the 5-item scale Cerebral Performance Category (CPC). Neurological status was retrospectively assessed at 6 months: CPC of 1 or 2 was defined as good neurological outcome and CPC of 3 to 5 were defined as poor neurological outcome. Deaths in the first 3 days and decisions to withdraw or to withhold life support were also collected. The following prognostication factors were tested: neurological examination at day 3 and 7 including corneal and pupillary reflexes, GCS-M, status epilepticus, electro-encephalogram (EEG), SSEPs and NSE levels between day 2 and day 3.
- Conditions
- Cardiac Arrest
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological functional status assessed by the 5-item scale Cerebral Performance Category (CPC) at 6 months.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startJan 2010
- Primary completionMar 2013
- Study completionMar 2013
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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888184
- Sponsor's protocol ID
- IRB 14 01 01
- Status last verified
- Aug 2016
- First submitted
- 30 Aug 2016
- Last updated
- 18 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuron Specific Enolase and Glasgow Motor Score Remain Useful Tools for Assessing Neurological Prognosis After Out-of-hospital Cardiac Arrest Treated With Therapeutic Hypothermia
- ClinicalTrials.gov ID
- NCT02888184
- Acronym / sponsor ID
- IRB 14 01 01
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Sep 2016 (estimated)
- 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.
The aim of the study is to identify prognostication predictors of 6-months neurological outcome in survivors at day 3 after cardiac arrest (CA) treated with therapeutic hypothermia (TH).
Detailed description
Cardiac arrest (CA) management remains challenging. As fewer than 20% of patients survive to discharge, early prognostication of functional outcome needs accurate prediction.Survivors outcome depends on initial CA conditions (cause, duration and severity of ischemic injury) that may lead to the post-cardiac arrest syndrome, associated with high mortality. Hypoxic-ischemic encephalopathy is the second cause of poor outcome after CA. Indeed, most survivors remain comatose or in a vegetative state leading to decisions to withdraw life support. Thus, the American Academy of Neurology had proposed a decision algorithm for use in prognostication of comatose survivors published in 2006.Before the widespread use of therapeutic hypothermia (TH), predictor factors of neurological outcome were: serum neuron-specific enolase (NSE), N20 somatosensory-evoked potentials (SSEP), status epilepticus, pupil and corneal reflexes and Glasgow coma score motor response (GCS-M). Therapeutic hypothermia is recommended in the management of CA.It has been associated with improved outcome after ventricular fibrillation out-of-hospital cardiac arrest (OHCA). However, TH may interfere with clinical examination and electrophysiological predictors (EEG, SSEP) making prognostication of functional outcome hardiest.The use of sedative drugs and muscle paralysis during TH is another cause of delayed neurological assessment and prognostication.The NSE cutoff values to predict poor neurological outcome are not well defined and can be influenced by TH either.The present study aims at identifying clinical, electrophysiological and biological prognostication predictors of 6-month neurological outcome in survivors at day 3 after CA treated by TH. Neurological functional status was assessed using the 5-item scale Cerebral Performance Category (CPC). Neurological status was retrospectively assessed at 6 months: CPC of 1 or 2 was defined as good neurological outcome and CPC of 3 to 5 were defined as poor neurological outcome. Deaths in the first 3 days and decisions to withdraw or to withhold life support were also collected. The following prognostication factors were tested: neurological examination at day 3 and 7 including corneal and pupillary reflexes, GCS-M, status epilepticus, electro-encephalogram (EEG), SSEPs and NSE levels between day 2 and day 3.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients (≥ 18 years) successfully resuscitated of out-of-hospital cardiac arrest (OHCA) and admitted to ICU.
Key inclusion criteria (3 listed)
- ≥ 18 years
- successfully resuscitated of out-of-hospital cardiac arrest (OHCA)
- patients admitted to ICU
Key exclusion criteria (2 listed)
- in-hospital cardiac arrest patients
- death before ICU admission
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
Neurological functional status assessed by the 5-item scale Cerebral Performance Category (CPC) at 6 months.
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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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 Universitaire de Nīmes 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neurological functional status assessed by the 5-item scale Cerebral Performance Category (CPC) at 6 months. (time frame: 6 month). 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 18 Jun 2026.