- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02888184
Identification of Neurological Prognostic Markers of Cardiac Arrest Patients Alive on 3rd Day
September 1, 2016 updated by: Centre Hospitalier Universitaire de Nīmes
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).
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
130
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All adult patients (≥ 18 years) successfully resuscitated of out-of-hospital cardiac arrest (OHCA) and admitted to ICU.
Description
Inclusion Criteria:
- ≥ 18 years
- successfully resuscitated of out-of-hospital cardiac arrest (OHCA)
- patients admitted to ICU
Exclusion Criteria:
- in-hospital cardiac arrest patients
- death before ICU admission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neurological functional status assessed by the 5-item scale Cerebral Performance Category (CPC) at 6 months.
Time Frame: 6 month
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
March 1, 2013
Study Registration Dates
First Submitted
August 30, 2016
First Submitted That Met QC Criteria
September 1, 2016
First Posted (ESTIMATE)
September 2, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
September 2, 2016
Last Update Submitted That Met QC Criteria
September 1, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 14 01 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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