Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY

NCT ID: NCT01980446

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2019-06-30

Brief Summary

Determination of vital and functional outcome in comatose survivors after cardiac arrest is principally based on the identification of predictors of non-awakening, using by clinical, biological and electrophysiological tools. In patients without presence of non-awakening predictors, it would be of interest to identify predictive criteria of awakening. The presence of mismatch negativity during the cortical auditory-evoked potential could contribute to further progress in neurological prognostication of these patients. However, at this time, its prognostic value has been insufficiently studied and the optimal time of realization remains unknown.

Detailed Description

We hypothesized that the presence of the mismatch negativity during the cortical auditory-evoked potential would predict a favorable outcome in comatose survivors after cardiac arrest.The main objective is to determine the capacity of the presence of the mismatch negativity during the cortical auditory-evoked potential to predict a 1-year favorable outcome in comatose survivors after cardiac arrest

The secondary objectives are:

• To assess the capacity of the presence of the mismatch negativity during the cortical auditory-evoked potential to predict awakening during the hospitalisation stay.
• To determine the optimal time of realization of the cortical auditory-evoked potential
• To determine the capacity of the presence of the mismatch negativity during the cortical auditory-evoked potential to predict ICU discharge and/or hospital discharge favorable outcome in comatose survivors after cardiac arrest
• To determine the impact of the sedations drugs during the hypothermia phase, and during the ICU stay The main judgement criterion is the 1-year CPC score (CPC 1 to 2 as a favorable outcome)

Study design : Prospective, multicentre, interventional study. Decision making to withdrawal of life support will be strictly codified according current knowledge and standardized among the participating centres. In the absence of predictors of non-awakening, care will be continued without limitation. The design of the study will focus on the determination of the capacity of the presence of the mismatch negativity during the cortical auditory-evoked potential to predict awakening. Cortical auditory-evoked potential will be performed bedside in the ICU by qualified neurophysiologists. Results of cortical auditory-evoked potential will remain blinded of bedside clinicians providing care for the patients. Awakening will be assessed bedside daily. CPC score will be evaluated at discharge of the ICU, of the hospital, at 3 months and 1 year by an independent evaluator, blinded of the results of the cortical auditory-evoked potentials.

Conditions

Coma; Cardiac Arrest

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1:Mismatch negativity

Presence of the mismatch negativity during the cortical auditory-evoked potential would predict a favorable outcome in comatose survivors after cardiac arrest.

Group Type: OTHER

Auditory-evoked potentials

Intervention Type: PROCEDURE

cortical auditory-evoked potentials are performed to all included patients at inclusion, at day 5 to day 10, day without sedation (up to 1 year), day of awakening

Interventions

Auditory-evoked potentials

cortical auditory-evoked potentials are performed to all included patients at inclusion, at day 5 to day 10, day without sedation (up to 1 year), day of awakening

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adults (age ≥ 18 years)
• hospitalized in the intensive care unit in the aftermath of a intra-or extra-hospital cardiac arrest
• alive but remaining comatose between the 2nd day and the 5th day after cardiopulmonary arrest

Exclusion Criteria

• moribund patients (treatment limitations or the life expectancy of the inclusion estimated at less than 1 year)
• patient awake at day of potential inclusion
• brain death state
• failure to realize the cortical
• patient whose hearing loss is known

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephane LEGRIEL, MD

Role: PRINCIPAL_INVESTIGATOR

Versailles Hospital - 78150 Le Chesnay - France

Locations

Lariboisière Hospital - Medical and toxicology unit

Paris, , France

Dr Stéphane LEGRIEL - Intensive Care Unit

Versailles, , France

Countries

France

Other Identifiers

2010-A01378-31

Identifier Type: OTHER

Identifier Source: secondary_id

P091118

Identifier Type: -

Identifier Source: org_study_id