Skip to main content
OpenTrials
Completed

NCT Number: NCT01980446

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lariboisière Hospital - Medical and toxicology unit, Paris, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory-evoked potentials

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

Primary outcomes

  1. CPC score of 1 or 2 (favorable outcome)

    Time frame: 1 year

    1-year CPC score of 1 or 2 (favorable outcome)

Secondary outcomes

  1. Awakeness

    Time frame: up to 1 year

    Awakeness during the hospitalisation stay

  2. Time of realization of the cortical auditory-evoked potential

    Time frame: up to 1 year

    the optimal time of realization of the cortical auditory-evoked potential

  3. CPC score of 1 or 2 at ICU discharge

    Time frame: up to 1 year

    the CPC score of 1 or 2 at ICU and at hospital discharge

  4. Length of mechanical ventilation, ICU stay, hospital stay and vital status at discharge

    Time frame: up to 1 year

    impact of the sedations drugs during the ICU stay impact of therapeutic hypothermia

  5. CPC score of 1 or 2 at hospital discharge

    Time frame: up to 1 year

    the CPC score of 1 or 2 at hospital discharge

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: CAPACITY

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Nov 11, 2013
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.