ComaCAPACITYNCT01980446
Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY
A study testing Auditory-evoked potentials in people with Coma and Cardiac Arrest, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coma, Cardiac Arrest
- What is being tested?
- Auditory-evoked potentials
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2013to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Lariboisière Hospital - Medical and toxicology unit
Paris, 75010
Dr Stéphane LEGRIEL - Intensive Care Unit
Versailles, 78150
About this study
Official title: Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY: The CAPACITY Study
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.
Read the 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
- Being tested
- Auditory-evoked potentials
- Keywords
- Coma, Cardiac arrest, Neurophysiology, Auditory evoked potential
- Medical subject headings
- Coma, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory-evoked potentialsProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 1:Mismatch negativity | Other | Presence of the mismatch negativity during the cortical auditory-evoked potential would predict a favorable outcome in comatose survivors after cardiac arrest. Receives: Procedure: Auditory-evoked potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPC score of 1 or 2 (favorable outcome)
1-year CPC score of 1 or 2 (favorable outcome)
Measured: 1 year
Secondary outcomes (5)
Awakeness
Awakeness during the hospitalisation stay
Measured: up to 1 year
Time of realization of the cortical auditory-evoked potential
the optimal time of realization of the cortical auditory-evoked potential
Measured: up to 1 year
CPC score of 1 or 2 at ICU discharge
the CPC score of 1 or 2 at ICU and at hospital discharge
Measured: up to 1 year
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
Measured: up to 1 year
CPC score of 1 or 2 at hospital discharge
the CPC score of 1 or 2 at hospital discharge
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephane LEGRIEL, MD, Principal investigator, Versailles Hospital - 78150 Le Chesnay - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980446
- Sponsor's protocol ID
- P091118
- Other IDs
- 2010-A01378-31
- Acronym
- CAPACITY
- Status last verified
- Aug 2020
- First submitted
- 24 Oct 2013
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY: The CAPACITY Study
- ClinicalTrials.gov ID
- NCT01980446
- Acronym / sponsor ID
- CAPACITY / P091118
- Conditions
- Coma, Cardiac Arrest
- Keywords
- Coma, Cardiac arrest, Neurophysiology, Auditory evoked potential
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1:Mismatch negativity | Other | Procedure: Auditory-evoked potentialsPresence of the mismatch negativity during the cortical auditory-evoked potential would predict a favorable outcome in comatose survivors after cardiac arrest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory-evoked potentialscortical 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 | Procedure or surgery | 1:Mismatch negativity |
Primary outcome
CPC score of 1 or 2 (favorable outcome)
Time frame: 1 year
1-year CPC score of 1 or 2 (favorable outcome)
5 secondary outcomes
Awakeness
Time frame: up to 1 year
Time of realization of the cortical auditory-evoked potential
Time frame: up to 1 year
CPC score of 1 or 2 at ICU discharge
Time frame: up to 1 year
Length of mechanical ventilation, ICU stay, hospital stay and vital status at discharge
Time frame: up to 1 year
CPC score of 1 or 2 at hospital discharge
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane LEGRIEL, MD principal investigator
Versailles Hospital - 78150 Le Chesnay - France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory-evoked potentials in people with Coma and Cardiac Arrest, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPC score of 1 or 2 (favorable outcome) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.