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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01980446
First received: October 24, 2013
Last updated: June 13, 2014
Last verified: June 2014
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    1-year CPC score of 1 or 2 (favorable outcome)


Secondary Outcome Measures:
  • Awakeness [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Awakeness during the hospitalisation stay

  • Time of realization of the cortical auditory-evoked potential [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    the CPC score of 1 or 2 at hospital discharge


Estimated Enrollment: 142
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 4th 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01980446     History of Changes
Other Study ID Numbers: P091118, 2010-A01378-31
Study First Received: October 24, 2013
Last Updated: June 13, 2014
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on October 01, 2014