Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY (CAPACITY)
Primary Purpose
Coma, Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Auditory-evoked potentials
Sponsored by
About this trial
This is an interventional other trial for Coma focused on measuring Coma, Cardiac arrest, Neurophysiology, Auditory evoked potential
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
Sites / Locations
- Lariboisière Hospital - Medical and toxicology unit
- Dr Stéphane LEGRIEL - Intensive Care Unit
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1:Mismatch negativity
Arm Description
Presence of the mismatch negativity during the cortical auditory-evoked potential would predict a favorable outcome in comatose survivors after cardiac arrest.
Outcomes
Primary Outcome Measures
CPC score of 1 or 2 (favorable outcome)
1-year CPC score of 1 or 2 (favorable outcome)
Secondary Outcome Measures
Awakeness
Awakeness during the hospitalisation stay
Time of realization of the cortical auditory-evoked potential
the optimal time of realization of the cortical auditory-evoked potential
CPC score of 1 or 2 at ICU discharge
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
impact of the sedations drugs during the ICU stay impact of therapeutic hypothermia
CPC score of 1 or 2 at hospital discharge
the CPC score of 1 or 2 at hospital discharge
Full Information
NCT ID
NCT01980446
First Posted
October 24, 2013
Last Updated
August 19, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01980446
Brief Title
Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY
Acronym
CAPACITY
Official Title
Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY: The CAPACITY Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coma, Cardiac Arrest
Keywords
Coma, Cardiac arrest, Neurophysiology, Auditory evoked potential
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1:Mismatch negativity
Arm Type
Other
Arm Description
Presence of the mismatch negativity during the cortical auditory-evoked potential would predict a favorable outcome in comatose survivors after cardiac arrest.
Intervention Type
Procedure
Intervention Name(s)
Auditory-evoked potentials
Intervention Description
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 Outcome Measure Information:
Title
CPC score of 1 or 2 (favorable outcome)
Description
1-year CPC score of 1 or 2 (favorable outcome)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Awakeness
Description
Awakeness during the hospitalisation stay
Time Frame
up to 1 year
Title
Time of realization of the cortical auditory-evoked potential
Description
the optimal time of realization of the cortical auditory-evoked potential
Time Frame
up to 1 year
Title
CPC score of 1 or 2 at ICU discharge
Description
the CPC score of 1 or 2 at ICU and at hospital discharge
Time Frame
up to 1 year
Title
Length of mechanical ventilation, ICU stay, hospital stay and vital status at discharge
Description
impact of the sedations drugs during the ICU stay impact of therapeutic hypothermia
Time Frame
up to 1 year
Title
CPC score of 1 or 2 at hospital discharge
Description
the CPC score of 1 or 2 at hospital discharge
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane LEGRIEL, MD
Organizational Affiliation
Versailles Hospital - 78150 Le Chesnay - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lariboisière Hospital - Medical and toxicology unit
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Dr Stéphane LEGRIEL - Intensive Care Unit
City
Versailles
ZIP/Postal Code
78150
Country
France
12. IPD Sharing Statement
Learn more about this trial
Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY
We'll reach out to this number within 24 hrs