Cardio Respiratory ArrestACRNCT02849561

Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest

A study testing Therapeutic hypothermia, Synchronized Intermittent Mandatory Ventilation and Electroencephalography in people with Cardio Respiratory Arrest, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

With the repercussion of 55 cases eachyear for 100 000 inhabitants in France, cardio respiratory arrest is a public health issue. The goal of this study is to evaluate the pupillary light reflex measured by the dimension of the pupil (diameter) as a prognosis factor neurological evolution in post cardiac arrest. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardio Respiratory Arrest
What is being tested?: Therapeutic hypothermia, Synchronized Intermittent Mandatory Ventilation and Electroencephalography
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteFrance
Study dates: Jan 2014to Jul 2015
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

Both gender
Entry in resuscitation after a cardiac arrest intra or extra-hospital
Resumption of a spontaneous cardiac activity
Affiliation to a social security system

Who cannot join

Refusal from patient or his family
Age under 18 years
Pregnant women
Previous neurological damages
Persons deprived of liberty by judicial or administrative decision

Trial locations and contacts

1 site in 1 country.

France1 site

UniversityHospitalGrenoble
La Tronche, 38700

Other trials in France

About this study

Official title: Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest : Prospective Study of Routine Care

With the repercussion of 55 cases eachyear for 100 000 inhabitants in France, cardio respiratory arrest is a public health issue.

The goal of this study is to evaluate the pupillary light reflex measured by the dimension of the pupil (diameter) as a prognosis factor neurological evolution in post cardiac arrest. By participating to this study, the patient get the same tratments and exams than in a usual managing cares.

In addition of these events, the pupillary light reflex is studied as soon as the patient is accepted in the department, and then on the second day.

Currently, the evaluation of the neurological becoming rely on a multimodal clinical and paraclinical approach.

The study of the pupillary light reflex measured by the diameter of the pupil could be a prognosis factor of neurological evolution for patients in post cardiac arrest, so a reliable and available prognosis marker in patient care.

The goal of this study is to evaluate the pupillary light reflex (RPM), measured by the diameter of the pupil as a prognosis factor of neurological evaluation of admitted patients after a cardiac arrest.

Principal criteria of judgement is the percentage of the pupillary light reflex variation measured with Neurolight®, compared between two groups.

Conditions: Cardio Respiratory Arrest
Being tested: Therapeutic hypothermia, Synchronized Intermittent Mandatory Ventilation, Electroencephalography, Pupillary light reflex surveillance, Transcranial Doppler
Keywords: Pupillary light reflex, Cardio respiratory arrest
Medical subject headings: Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Therapeutic hypothermiaOther
With a mattress at 4°C to reach a central temperature at 33,5°C.
Synchronized Intermittent Mandatory VentilationDevice
Also called SIMV
Constant volume 6 ml/kg
ElectroencephalographyOther
Also called EEG
Pupillary light reflex surveillanceDevice
With Neurolight® device.
Transcranial DopplerDevice
Monitoring tool for brain hemodynamic evaluation. With Philips HD15 Ultrasound system®.

Study groups in NCT02849561
Study group	Role	What they receive
Favourable neurological evolution after cardiac arrest	Active comparator	MGOS 4-5 Receives: Other: Therapeutic hypothermia; Device: Synchronized Intermittent Mandatory Ventilation; Other: Electroencephalography; Device: Pupillary light reflex surveillance; Device: Transcranial Doppler
Unfavourable neurological evolution after cardiac arrest	Active comparator	MGOS 1-3 Receives: Other: Therapeutic hypothermia; Device: Synchronized Intermittent Mandatory Ventilation; Other: Electroencephalography; Device: Pupillary light reflex surveillance; Device: Transcranial Doppler

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of the pupillary light reflex variation measured with Neurolight®
Compared between two groups. Favourable neurological evolution after cardiac arrest : MGOS 4-5 Unfavourable neurological evolution after cardiac arrest MGOS 1-3
Measured: One second

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Jul 2015

First posted29 Jul 2016 (estimated)
Study startJan 2014
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)Papers the sponsor has linked to this study.
Other trials for Cardio Respiratory ArrestStudies of the same condition, open and under way.
More trials run by University Hospital, GrenobleThe 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: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02849561
Sponsor's protocol ID: 38RC13.713
Acronym: ACR
Status last verified: Jul 2016
First submitted: 21 Jul 2016
Last updated: 29 Jul 2016
Results posted: No
Data monitoring committee: No

Publications

Gorgels AP, Gijsbers C, de Vreede-Swagemakers J, Lousberg A, Wellens HJ. Out-of-hospital cardiac arrest--the relevance of heart failure. The Maastricht Circulatory Arrest Registry. Eur Heart J. 2003 Jul;24(13):1204-9. doi: 10.1016/s0195-668x(03)00191-x.
PubMed 12831814
Jennett B, Plum F. Persistent vegetative state after brain damage. A syndrome in search of a name. Lancet. 1972 Apr 1;1(7753):734-7. doi: 10.1016/s0140-6736(72)90242-5. No abstract available.
PubMed 4111204
Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349.
PubMed 11839831
Rogove HJ, Safar P, Sutton-Tyrrell K, Abramson NS. Old age does not negate good cerebral outcome after cardiopulmonary resuscitation: analyses from the brain resuscitation clinical trials. The Brain Resuscitation Clinical Trial I and II Study Groups. Crit Care Med. 1995 Jan;23(1):18-25. doi: 10.1097/00003246-199501000-00007.
PubMed 8001370
Wijdicks EF, Hijdra A, Young GB, Bassetti CL, Wiebe S; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: prediction of outcome in comatose survivors after cardiopulmonary resuscitation (an evidence-based review) [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006 Jul 25;67(2):203-10. doi: 10.1212/01.wnl.0000227183.21314.cd.
PubMed 16864809
Edgren E, Hedstrand U, Kelsey S, Sutton-Tyrrell K, Safar P. Assessment of neurological prognosis in comatose survivors of cardiac arrest. BRCT I Study Group. Lancet. 1994 Apr 30;343(8905):1055-9. doi: 10.1016/s0140-6736(94)90179-1.
PubMed 7909098
Kamps MJ, Horn J, Oddo M, Fugate JE, Storm C, Cronberg T, Wijman CA, Wu O, Binnekade JM, Hoedemaekers CW. Prognostication of neurologic outcome in cardiac arrest patients after mild therapeutic hypothermia: a meta-analysis of the current literature. Intensive Care Med. 2013 Oct;39(10):1671-82. doi: 10.1007/s00134-013-3004-y. Epub 2013 Jun 26.
PubMed 23801384
Fischer C, Luaute J, Nemoz C, Morlet D, Kirkorian G, Mauguiere F. Improved prediction of awakening or nonawakening from severe anoxic coma using tree-based classification analysis. Crit Care Med. 2006 May;34(5):1520-4. doi: 10.1097/01.CCM.0000215823.36344.99.
PubMed 16557163
Jorgensen EO. Course of neurological recovery and cerebral prognostic signs during cardio-pulmonary resuscitation. Resuscitation. 1997 Aug;35(1):9-16. doi: 10.1016/s0300-9572(97)00022-1.
PubMed 9259054
Meeker M, Du R, Bacchetti P, Privitera CM, Larson MD, Holland MC, Manley G. Pupil examination: validity and clinical utility of an automated pupillometer. J Neurosci Nurs. 2005 Feb;37(1):34-40.
PubMed 15794443
Behrends M, Niemann CU, Larson MD. Infrared pupillometry to detect the light reflex during cardiopulmonary resuscitation: a case series. Resuscitation. 2012 Oct;83(10):1223-8. doi: 10.1016/j.resuscitation.2012.05.013. Epub 2012 May 30.
PubMed 22659054
Taylor WR, Chen JW, Meltzer H, Gennarelli TA, Kelbch C, Knowlton S, Richardson J, Lutch MJ, Farin A, Hults KN, Marshall LF. Quantitative pupillometry, a new technology: normative data and preliminary observations in patients with acute head injury. Technical note. J Neurosurg. 2003 Jan;98(1):205-13. doi: 10.3171/jns.2003.98.1.0205.
PubMed 12546375
Horburger D, Testori C, Sterz F, Herkner H, Krizanac D, Uray T, Schober A, Stockl M, Stratil P, Weiser C, Wallmuller C, Holzer M. Mild therapeutic hypothermia improves outcomes compared with normothermia in cardiac-arrest patients--a retrospective chart review. Crit Care Med. 2012 Aug;40(8):2315-9. doi: 10.1097/CCM.0b013e31825333cf.
PubMed 22622403
Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
PubMed 11856794
Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.
PubMed 11856793

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardio Respiratory Arrest trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest : Prospective Study of Routine Care
ClinicalTrials.gov ID: NCT02849561
Acronym / sponsor ID: ACR / 38RC13.713
Conditions: Cardio Respiratory Arrest
Keywords: Pupillary light reflex, Cardio respiratory arrest
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: University Hospital, GrenobleUniversity, hospital or other
Study start: Jan 2014
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 29 Jul 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.

With the repercussion of 55 cases eachyear for 100 000 inhabitants in France, cardio respiratory arrest is a public health issue.

In addition of these events, the pupillary light reflex is studied as soon as the patient is accepted in the department, and then on the second day.

Currently, the evaluation of the neurological becoming rely on a multimodal clinical and paraclinical approach.

Principal criteria of judgement is the percentage of the pupillary light reflex variation measured with Neurolight®, compared between two groups.

Study design

Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Favourable neurological evolution after cardiac arrest	Active comparator	Other: Therapeutic hypothermia, Device: Synchronized Intermittent Mandatory Ventilation, Other: Electroencephalography, Device: Pupillary light reflex surveillance, Device: Transcranial DopplerMGOS 4-5
Unfavourable neurological evolution after cardiac arrest	Active comparator	Other: Therapeutic hypothermia, Device: Synchronized Intermittent Mandatory Ventilation, Other: Electroencephalography, Device: Pupillary light reflex surveillance, Device: Transcranial DopplerMGOS 1-3

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Both gender
Entry in resuscitation after a cardiac arrest intra or extra-hospital
Resumption of a spontaneous cardiac activity
Affiliation to a social security system

Key exclusion criteria (5 listed)

Refusal from patient or his family
Age under 18 years
Pregnant women
Previous neurological damages
Persons deprived of liberty by judicial or administrative decision

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
Therapeutic hypothermiaWith a mattress at 4°C to reach a central temperature at 33,5°C.	Other	Favourable neurological evolution after cardiac arrest, Unfavourable neurological evolution after cardiac arrest
Synchronized Intermittent Mandatory VentilationAlso: SIMVConstant volume 6 ml/kg	Device	Favourable neurological evolution after cardiac arrest, Unfavourable neurological evolution after cardiac arrest
ElectroencephalographyAlso: EEG	Other	Favourable neurological evolution after cardiac arrest, Unfavourable neurological evolution after cardiac arrest
Pupillary light reflex surveillanceWith Neurolight® device.	Device	Favourable neurological evolution after cardiac arrest, Unfavourable neurological evolution after cardiac arrest
Transcranial DopplerMonitoring tool for brain hemodynamic evaluation. With Philips HD15 Ultrasound system®.	Device	Favourable neurological evolution after cardiac arrest, Unfavourable neurological evolution after cardiac arrest

Primary outcome

Percentage of the pupillary light reflex variation measured with Neurolight®
Time frame: One second
Compared between two groups. Favourable neurological evolution after cardiac arrest : MGOS 4-5 Unfavourable neurological evolution after cardiac arrest MGOS 1-3

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 29 Jul 2016.
Background: PubMed 12831814Gorgels AP, Gijsbers C, de Vreede-Swagemakers J, Lousberg A, Wellens HJ. Out-of-hospital cardiac arrest--the relevance of heart failure. The Maastricht Circulatory Arrest Registry. Eur Heart J. 2003 Jul;24(13):1204-9. doi: 10.1016/s0195-668x(03)00191-x.
Background: PubMed 4111204Jennett B, Plum F. Persistent vegetative state after brain damage. A syndrome in search of a name. Lancet. 1972 Apr 1;1(7753):734-7. doi: 10.1016/s0140-6736(72)90242-5. No abstract available.
Background: PubMed 11839831Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349.
Background: PubMed 8001370Rogove HJ, Safar P, Sutton-Tyrrell K, Abramson NS. Old age does not negate good cerebral outcome after cardiopulmonary resuscitation: analyses from the brain resuscitation clinical trials. The Brain Resuscitation Clinical Trial I and II Study Groups. Crit Care Med. 1995 Jan;23(1):18-25. doi: 10.1097/00003246-199501000-00007.
Background: PubMed 16864809Wijdicks EF, Hijdra A, Young GB, Bassetti CL, Wiebe S; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: prediction of outcome in comatose survivors after cardiopulmonary resuscitation (an evidence-based review) [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006 Jul 25;67(2):203-10. doi: 10.1212/01.wnl.0000227183.21314.cd.
Background: PubMed 7909098Edgren E, Hedstrand U, Kelsey S, Sutton-Tyrrell K, Safar P. Assessment of neurological prognosis in comatose survivors of cardiac arrest. BRCT I Study Group. Lancet. 1994 Apr 30;343(8905):1055-9. doi: 10.1016/s0140-6736(94)90179-1.
Background: PubMed 23801384Kamps MJ, Horn J, Oddo M, Fugate JE, Storm C, Cronberg T, Wijman CA, Wu O, Binnekade JM, Hoedemaekers CW. Prognostication of neurologic outcome in cardiac arrest patients after mild therapeutic hypothermia: a meta-analysis of the current literature. Intensive Care Med. 2013 Oct;39(10):1671-82. doi: 10.1007/s00134-013-3004-y. Epub 2013 Jun 26.
Background: PubMed 16557163Fischer C, Luaute J, Nemoz C, Morlet D, Kirkorian G, Mauguiere F. Improved prediction of awakening or nonawakening from severe anoxic coma using tree-based classification analysis. Crit Care Med. 2006 May;34(5):1520-4. doi: 10.1097/01.CCM.0000215823.36344.99.
Background: PubMed 9259054Jorgensen EO. Course of neurological recovery and cerebral prognostic signs during cardio-pulmonary resuscitation. Resuscitation. 1997 Aug;35(1):9-16. doi: 10.1016/s0300-9572(97)00022-1.
Background: PubMed 15794443Meeker M, Du R, Bacchetti P, Privitera CM, Larson MD, Holland MC, Manley G. Pupil examination: validity and clinical utility of an automated pupillometer. J Neurosci Nurs. 2005 Feb;37(1):34-40.
Background: PubMed 22659054Behrends M, Niemann CU, Larson MD. Infrared pupillometry to detect the light reflex during cardiopulmonary resuscitation: a case series. Resuscitation. 2012 Oct;83(10):1223-8. doi: 10.1016/j.resuscitation.2012.05.013. Epub 2012 May 30.
Background: PubMed 12546375Taylor WR, Chen JW, Meltzer H, Gennarelli TA, Kelbch C, Knowlton S, Richardson J, Lutch MJ, Farin A, Hults KN, Marshall LF. Quantitative pupillometry, a new technology: normative data and preliminary observations in patients with acute head injury. Technical note. J Neurosurg. 2003 Jan;98(1):205-13. doi: 10.3171/jns.2003.98.1.0205.

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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.

Michel Durand, Doctor principal investigator

Grenoble Hospital University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 29 Jul 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?

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?

Percentage of the pupillary light reflex variation measured with Neurolight® (time frame: One second). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02849561, which also lists 32 linked publications.

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 29 Jul 2016.