NCT03737747

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4 years

First QC Date

November 8, 2018

Last Update Submit

May 9, 2023

Conditions

Keywords

Synek scoreelectroencephalographycardiac arrest

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is the CPC 3-5 score at 3 months or at death time

    at 3 months

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Age ≥ 18 years with inclusion criteria : Will be considered for inclusion 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 and an 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, and patients with missing data

You may qualify if:

  • 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

You may not qualify if:

  • moribund patients
  • awoke within the first 48 hours of admission
  • neurologic causes of CA
  • patients with missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Amiens Picardie

Amiens, 80000, France

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 9, 2018

Study Start

November 1, 2013

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations