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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • CHU de Nîmes

    Nîmes, Gard, 30029

Other trials in France

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.

  1. 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.

  1. First posted2 Sep 2016 (estimated)
  2. Study startJan 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

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)
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

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.

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