Cardiorespiratory ArrestCA-EEGNCT02886039
Predictive Electrophysiological Score of the Neurological Prognosis Post Cardiac Arrest
A study testing Electroencephalogram in people with Cardiorespiratory Arrest, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Cardiac arrest (CA) is a major public health problem (1) because of its frequency (30000 to 50000 new cases of CA per year in France), a high mortality 80-90% and a relevant morbidity : 50% of survivors have cerebral sequela. Neurologic prognostication after CA is paramount. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiorespiratory Arrest
- What is being tested?
- Electroencephalogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Dec 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
- Patient > 18 years, hospitalized in resuscitation
- Cardiac arrest in hospital or out
- Collection of the written and informed consent
Who cannot join
- Cardiorespiratory arrest concomitant with a neurological, traumatic or toxic pathology
- History of cerebrovascular accident or cerebral anoxia
- Patient whose family did not give an informed consent
- Patient < 18 years
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Lapeyronie - Département Anesthésie Réanimation A
Montpellier, 34295
Jean-Paul ROUSTAN, MH, PhD, 04 67 33 82 56, JP-ROUSTAN@CHU-MONTPELLIER.FR
About this study
Cardiac arrest (CA) is a major public health problem (1) because of its frequency (30000 to 50000 new cases of CA per year in France), a high mortality 80-90% and a relevant morbidity : 50% of survivors have cerebral sequela. Neurologic prognostication after CA is paramount. The American Academy of Neurology identifies accurate predictors of poor neurologic outcome (2): clinical examination findings such as no pupil response, no corneal reflexes, no motor response to stimulation and early myoclonus status epilepticus; biologic parameters like high neuron specific enolase (NSE) greater than 33 μg/L (3-4) and electrophysiologic results like flat electroencephalogram (EEG) or with burst suppression and Somatosensory evoked potentials (SEP) with no response to N20. Brain imaging may provide additional informations but not recommended yet. However, these pronotic markers were developed before the introduction therapeutic hypothermia (TH) (5-6). TH is now recommended after cardiac arrest by international guidelines, based on demonstration of improved survival and neurological recovery in comatose survivors of CA (7). TH and its associated use of sedative and paralytic agent may delay neurologic recovery and affect the optimal timing of prognostic variables (8).
Many classifications of electroencephalogram (EEG) (9-12) exist but no one is generally accept and recommended and they were created before TH.
Read more
In a preliminary study based on a retrospective cohort of 64 patients in CA with initial TH, we developped an electroencephalographic score to predict precocity the neurologic outcome according to the Cerebral performance category (CPC) (13-14).
The purpose of this study is to evaluate a simple and objective electroencephalographic score helpful to predict neurologic outcome after CA. Then, we would like to create a composite score to have a multimodal prognostication.
Patients and methods After CA resuscitation, all patients underwent coronary angioplasty if indicated and then were immediately admitted in emergency room of ICU. All patients were intubated and mechanically ventilated. Sedation was performed with continuous infusion of midazolam 0,15-0,2 mg/kg/h and sufentanil 0,15-0,2 μg/kg/h. All our patients were curarized with cisatracurium 0,2-0,3 mg/kg/h to prevent shivering during TH and took anti-epileptic medication phenobarbital 10-15 mg/ kg two times a day to prevent infra-clinic convulsive seizure.
Mild TH between 33 -34 °C was performed by active cooling with intravascular device (CoolGard® - Zoll, Chelmsford, UK) for 24 hours. Mean arterial pressure was maintained between [75-80] mmHg by titrated norepinephrine with or without inotropics (dobutamine, epinephrine) according cardiac output monitored by echocardiography.
After 24 hours of hypothermia, warming was started at a rate of 0.2 ° C/hr; neuromuscular blocking agents were arrested at 35.5°C and sedation at 36.5°C.
Neurological evaluation performed at 48 hours off sedation included a clinical evaluation (Glasgow score, myoclonus status, response to orders, motor response to stimulation, brain-stem reflexes). NSE was sampled between 48 and 72 H. EEGs were performed at Day-2, Day-3 and Day-5 off sedation and SEP at Day-5 off sedation. All EEGs were interpreted by two certified electroencephalographers blind from clinical neurologic outcome.
Survival and neurologic outcome according to CPC were assessed at ICU discharge and three months later.
Read the detailed description
Electroencephalographic score
Reactivity Absence 1 Presence 0 Dominant frequency α (8-12 Hz) 0 θ (4-7,5 Hz) 1 δ (< 4 Hz) 2 Amplitude > 10 μV 0 < 10 μV 1 GPDs Absence 0 Presence 1 Burst Suppression Absence 0 Presence 1 Paroxysmal activity Absence 0 Presence 1
TOTAL
- Conditions
- Cardiorespiratory Arrest
- Being tested
- Electroencephalogram
- Keywords
- Cardiorespiratory arrest, Neurologic outcome, Electroencephalogram, Somatosensory evoked potential, Synek classification, Cerebral performance category, Hypothermia
- Medical subject headings
- Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalogramOther
Prognostic evaluation of electroencephalogram score created with a retrospective cohort Creation of composite score to predict neurologic outcome in cardiorespiratory arrest
| Study group | Role | What they receive |
|---|---|---|
| patients | Other | Patient with cardiac arrest benefiting an electroencephalogram Receives: Other: Electroencephalogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of electroencephalogram score to neurologic outcome evaluated by cerebral performance category
Intensive care unit discharge
Measured: J0 (date of inclusion)
Secondary outcomes (1)
comparison of electroencephalogram score to neurologic outcome evaluated by cerebral performance category
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startJun 2014
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespiratory ArrestStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Paul ROUSTAN, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886039
- Sponsor's protocol ID
- UF 9389
- Acronym
- CA-EEG
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Electrophysiological Score of the Neurological Prognosis Post Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02886039
- Acronym / sponsor ID
- CA-EEG / UF 9389
- Conditions
- Cardiorespiratory Arrest
- Keywords
- Cardiorespiratory arrest, Neurologic outcome, Electroencephalogram, Somatosensory evoked potential, Synek classification, Cerebral performance category, Hypothermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Sep 2016 (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.
Cardiac arrest (CA) is a major public health problem (1) because of its frequency (30000 to 50000 new cases of CA per year in France), a high mortality 80-90% and a relevant morbidity : 50% of survivors have cerebral sequela. Neurologic prognostication after CA is paramount. The American Academy of Neurology identifies accurate predictors of poor neurologic outcome (2): clinical examination findings such as no pupil response, no corneal reflexes, no motor response to stimulation and early myoclonus status epilepticus; biologic parameters like high neuron specific enolase (NSE) greater than 33 μg/L (3-4) and electrophysiologic results like flat electroencephalogram (EEG) or with burst suppression and Somatosensory evoked potentials (SEP) with no response to N20. Brain imaging may provide additional informations but not recommended yet. However, these pronotic markers were developed before the introduction therapeutic hypothermia (TH) (5-6). TH is now recommended after cardiac arrest by international guidelines, based on demonstration of improved survival and neurological recovery in comatose survivors of CA (7). TH and its associated use of sedative and paralytic agent may delay neurologic recovery and affect the optimal timing of prognostic variables (8).
Many classifications of electroencephalogram (EEG) (9-12) exist but no one is generally accept and recommended and they were created before TH.
In a preliminary study based on a retrospective cohort of 64 patients in CA with initial TH, we developped an electroencephalographic score to predict precocity the neurologic outcome according to the Cerebral performance category (CPC) (13-14).
The purpose of this study is to evaluate a simple and objective electroencephalographic score helpful to predict neurologic outcome after CA. Then, we would like to create a composite score to have a multimodal prognostication.
Patients and methods After CA resuscitation, all patients underwent coronary angioplasty if indicated and then were immediately admitted in emergency room of ICU. All patients were intubated and mechanically ventilated. Sedation was performed with continuous infusion of midazolam 0,15-0,2 mg/kg/h and sufentanil 0,15-0,2 μg/kg/h. All our patients were curarized with cisatracurium 0,2-0,3 mg/kg/h to prevent shivering during TH and took anti-epileptic medication phenobarbital 10-15 mg/ kg two times a day to prevent infra-clinic convulsive seizure.
Mild TH between 33 -34 °C was performed by active cooling with intravascular device (CoolGard® - Zoll, Chelmsford, UK) for 24 hours. Mean arterial pressure was maintained between [75-80] mmHg by titrated norepinephrine with or without inotropics (dobutamine, epinephrine) according cardiac output monitored by echocardiography.
After 24 hours of hypothermia, warming was started at a rate of 0.2 ° C/hr; neuromuscular blocking agents were arrested at 35.5°C and sedation at 36.5°C.
Neurological evaluation performed at 48 hours off sedation included a clinical evaluation (Glasgow score, myoclonus status, response to orders, motor response to stimulation, brain-stem reflexes). NSE was sampled between 48 and 72 H. EEGs were performed at Day-2, Day-3 and Day-5 off sedation and SEP at Day-5 off sedation. All EEGs were interpreted by two certified electroencephalographers blind from clinical neurologic outcome.
Survival and neurologic outcome according to CPC were assessed at ICU discharge and three months later.
Detailed description
Electroencephalographic score
Reactivity Absence 1 Presence 0 Dominant frequency α (8-12 Hz) 0 θ (4-7,5 Hz) 1 δ (< 4 Hz) 2 Amplitude > 10 μV 0 < 10 μV 1 GPDs Absence 0 Presence 1 Burst Suppression Absence 0 Presence 1 Paroxysmal activity Absence 0 Presence 1
TOTAL
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Other | Other: ElectroencephalogramPatient with cardiac arrest benefiting an electroencephalogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient > 18 years, hospitalized in resuscitation
- Cardiac arrest in hospital or out
- Collection of the written and informed consent
Key exclusion criteria (4 listed)
- Cardiorespiratory arrest concomitant with a neurological, traumatic or toxic pathology
- History of cerebrovascular accident or cerebral anoxia
- Patient whose family did not give an informed consent
- Patient < 18 years
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 |
|---|---|---|
| ElectroencephalogramPrognostic evaluation of electroencephalogram score created with a retrospective cohort Creation of composite score to predict neurologic outcome in cardiorespiratory arrest | Other | patients |
Primary outcome
comparison of electroencephalogram score to neurologic outcome evaluated by cerebral performance category
Time frame: J0 (date of inclusion)
Intensive care unit discharge
1 secondary outcome
comparison of electroencephalogram score to neurologic outcome evaluated by cerebral performance category
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Individual participant dataSharing planned: Yes
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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.
Jean Paul ROUSTAN, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalogram in people with Cardiorespiratory Arrest, run by University Hospital, Montpellier at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Paul ROUSTAN, MD, PhD (04 67 33 82 56, JP-ROUSTAN@CHU-MONTPELLIER.FR), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of electroencephalogram score to neurologic outcome evaluated by cerebral performance category (time frame: J0 (date of inclusion)). 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 1 Sep 2016.