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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03737747
Other study ID # PI2018_843_0045
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2013
Est. completion date November 1, 2017

Study information

Verified date May 2023
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Resuscitated cardiac arrest (CA) is a frequent cause of admission in intensive care unit (ICU). Neurological state of postanoxic comatose patients can evolve either towards the absence of awakening or towards a more or less altered state of consciousness, ranging from the vegetative state to the full recovery of cognitive functions. Most of the deaths result from active withdrawal of life-sustaining treatment, based on poor neurological outcome prediction. Neurological prognostication needs therefore a multimodal approach based on reliable parameters, which should be easy to access and available at the early stage of care, in attempt to limit false poor outcome prognostication and help to not prolong futile active care in patient with severe post anoxic cerebral lesions. Nowadays the prediction of neurological outcome relies on a multimodal strategy including clinical examination, biomarkers and electroencephalography (Guidelines ESICM 2015). Early standard electroencephalography (EEG) is currently recommended and some features, notably absence of reactivity, status epilepticus or burst suppression after rewarming are strongly predictive of poor outcome. But those features require a precise analyze of the EEG usually performed by specialist. EEG patterns can be simplified and classified in five grades according to the Synek classification, ranging from dominant reactive alpha activity (grade 1) to isoelectric encephalogram (grade 5). Grade 1 and two are considering as good prognostic, grade 3 as intermediate and grade 4 to five as poor prognostic. Nevertheless, few data are available on the performance of this classification since generalization of TTM use. We hypothesize that a multimodal strategy combining clinical examination, NSE concentration and the Synek score would bring a high degree of prediction. We aimed to assess the performances of the combination of clinical examination, NSE analysed at 48-72h and the Synek score to predict hard outcome defined by a cerebral performance category (CPC) 3-5, in postanoxic comatose patients treated with induced hypothermia


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date November 1, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients admitted in our ICU following a resuscitate cardiac arrest between November 1, 2013 to November 1, 2017 - treated with 33° induced hypothermia for 24 h - having at least one early EEG rated according to Synek score - available dosage of NSE performed within 48-72h post CA Exclusion Criteria: - moribund patients - awoke within the first 48 hours of admission - neurologic causes of CA - patients with missing data

Study Design


Related Conditions & MeSH terms

  • Coma
  • Hypothermia
  • Prediction by the Synek Score of Poor Neurological Outcome in Postanoxic Comatose Patients Treated With Induced Hypothermia

Intervention

Procedure:
induced hypothermia


Locations

Country Name City State
France Chu Amiens Picardie Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome is the CPC 3-5 score at 3 months or at death time at 3 months