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

This study is currently recruiting participants.
Verified May 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT01980446
First Posted: November 11, 2013
Last Update Posted: May 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Coma Cardiac Arrest Procedure: Auditory-evoked potentials

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY: The CAPACITY Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • CPC score of 1 or 2 (favorable outcome) [ Time Frame: 1 year ]
    1-year CPC score of 1 or 2 (favorable outcome)


Secondary Outcome Measures:
  • Awakeness [ Time Frame: up to 1 year ]
    Awakeness during the hospitalisation stay

  • 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

  • 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

  • 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

  • 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


Estimated Enrollment: 142
Study Start Date: December 2013
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: 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

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980446


Contacts
Contact: Stéphane LEGRIEL, MD 33 1 39 63 88 39 slegriel@ch-versailles.fr
Contact: Nicolas DEYE, MD 33 1 49 95 64 91 nicolas.deye@lrb.aphp.fr

Locations
France
Lariboisière Hospital - Medical and toxicology unit Not yet recruiting
Paris, France, 75010
Contact: Nicolas DEYE, MD    01 49 95 64 91    nicolas.deye@lrb.aphp.fr   
Dr Stéphane LEGRIEL - Intensive Care Unit Recruiting
Versailles, France, 78150
Contact: Stéphane LEGRIEL, MD    : 33 1 39 63 88 39    slegriel@ch-versailles.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Stephane LEGRIEL, MD Versailles Hospital - 78150 Le Chesnay - France
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01980446     History of Changes
Other Study ID Numbers: P091118
2010-A01378-31 ( Other Identifier: IDRCB )
First Submitted: October 24, 2013
First Posted: November 11, 2013
Last Update Posted: May 10, 2016
Last Verified: May 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Coma
Cardiac arrest
Neurophysiology
Auditory evoked potential

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases