Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-02-01 @ 6:14 AM
Study NCT ID:
NCT02849561
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2016-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007036', 'term': 'Hypothermia, Induced'}, {'id': 'D017585', 'term': 'Ultrasonography, Doppler, Transcranial'}], 'ancestors': [{'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004453', 'term': 'Echoencephalography'}, {'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-26', 'studyFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of the pupillary light reflex variation measured with Neurolight®', 'timeFrame': 'One second', 'description': 'Compared between two groups. Favourable neurological evolution after cardiac arrest : MGOS 4-5 Unfavourable neurological evolution after cardiac arrest MGOS 1-3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pupillary light reflex', 'Cardio respiratory arrest'], 'conditions': ['Cardio Respiratory Arrest']}, 'referencesModule': {'references': [{'pmid': '12831814', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '4111204', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11839831', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8001370', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16864809', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7909098', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23801384', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16557163', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9259054', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15794443', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22659054', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12546375', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22622403', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11856794', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11856793', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21187745', 'type': 'BACKGROUND', 'citation': 'Nunnally ME, Jaeschke R, Bellingan GJ, Lacroix J, Mourvillier B, Rodriguez-Vega GM, Rubertsson S, Vassilakopoulos T, Weinert C, Zanotti-Cavazzoni S, Buchman TG. Targeted temperature management in critical care: a report and recommendations from five professional societies. Crit Care Med. 2011 May;39(5):1113-25. doi: 10.1097/CCM.0b013e318206bab2.'}, {'pmid': '20129438', 'type': 'BACKGROUND', 'citation': 'Nolan JP, Neumar RW, Adrie C, Aibiki M, Berg RA, Bbttiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T; International Liaison Committee on Resuscitation; Emergency Cardiovascular Care Committee, American Heart Association; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiopulmonary, Perioperative, and Critical Care; Council on Clinical Cardiology; Council on Stroke. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication: a scientific statement from the International Liaison Committee on Resuscitation; the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; the Council on Stroke (Part II). Int Emerg Nurs. 2010 Jan;18(1):8-28. doi: 10.1016/j.ienj.2009.07.001. Epub 2009 Aug 5.'}, {'pmid': '1774392', 'type': 'BACKGROUND', 'citation': 'Gueugniaud PY, Garcia-Darennes F, Gaussorgues P, Bancalari G, Petit P, Robert D. Prognostic significance of early intracranial and cerebral perfusion pressures in post-cardiac arrest anoxic coma. Intensive Care Med. 1991;17(7):392-8. doi: 10.1007/BF01720676.'}, {'pmid': '22012818', 'type': 'BACKGROUND', 'citation': 'Alvarez-Fernandez JA. [Transcranial Doppler ultrasound use in post-cardiac arrest coma]. Rev Neurol. 2011 Nov 1;53(9):545-54. Spanish.'}, {'pmid': '17169697', 'type': 'BACKGROUND', 'citation': 'Wessels T, Harrer JU, Jacke C, Janssens U, Klotzsch C. The prognostic value of early transcranial Doppler ultrasound following cardiopulmonary resuscitation. Ultrasound Med Biol. 2006 Dec;32(12):1845-51. doi: 10.1016/j.ultrasmedbio.2006.06.023.'}, {'pmid': '3621954', 'type': 'BACKGROUND', 'citation': 'Edgren E, Hedstrand U, Nordin M, Rydin E, Ronquist G. Prediction of outcome after cardiac arrest. Crit Care Med. 1987 Sep;15(9):820-5. doi: 10.1097/00003246-198709000-00004.'}, {'pmid': '9851380', 'type': 'BACKGROUND', 'citation': 'Zandbergen EG, de Haan RJ, Stoutenbeek CP, Koelman JH, Hijdra A. Systematic review of early prediction of poor outcome in anoxic-ischaemic coma. Lancet. 1998 Dec 5;352(9143):1808-12. doi: 10.1016/S0140-6736(98)04076-8.'}, {'pmid': '16924008', 'type': 'BACKGROUND', 'citation': 'Zandbergen EG, Koelman JH, de Haan RJ, Hijdra A; PROPAC-Study Group. SSEPs and prognosis in postanoxic coma: only short or also long latency responses? Neurology. 2006 Aug 22;67(4):583-6. doi: 10.1212/01.wnl.0000230162.35249.7f.'}, {'pmid': '11534570', 'type': 'BACKGROUND', 'citation': 'Nakabayashi M, Kurokawa A, Yamamoto Y. Immediate prediction of recovery of consciousness after cardiac arrest. Intensive Care Med. 2001 Jul;27(7):1210-4. doi: 10.1007/s001340100984.'}, {'pmid': '11085552', 'type': 'BACKGROUND', 'citation': 'Rothstein TL. The role of evoked potentials in anoxic-ischemic coma and severe brain trauma. J Clin Neurophysiol. 2000 Sep;17(5):486-97. doi: 10.1097/00004691-200009000-00007.'}, {'pmid': '17990124', 'type': 'BACKGROUND', 'citation': 'Vanhaudenhuyse A, Laureys S, Perrin F. Cognitive event-related potentials in comatose and post-comatose states. Neurocrit Care. 2008;8(2):262-70. doi: 10.1007/s12028-007-9016-0.'}, {'pmid': '23148350', 'type': 'BACKGROUND', 'citation': 'Tzovara A, Rossetti AO, Spierer L, Grivel J, Murray MM, Oddo M, De Lucia M. Progression of auditory discrimination based on neural decoding predicts awakening from coma. Brain. 2013 Jan;136(Pt 1):81-9. doi: 10.1093/brain/aws264. Epub 2012 Nov 12.'}, {'pmid': '1860248', 'type': 'BACKGROUND', 'citation': 'Cummins RO, Chamberlain DA, Abramson NS, Allen M, Baskett PJ, Becker L, Bossaert L, Delooz HH, Dick WF, Eisenberg MS, et al. Recommended guidelines for uniform reporting of data from out-of-hospital cardiac arrest: the Utstein Style. A statement for health professionals from a task force of the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian Resuscitation Council. Circulation. 1991 Aug;84(2):960-75. doi: 10.1161/01.cir.84.2.960. No abstract available.'}, {'pmid': '46957', 'type': 'BACKGROUND', 'citation': 'Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet. 1975 Mar 1;1(7905):480-4. doi: 10.1016/s0140-6736(75)92830-5.'}, {'pmid': '23942856', 'type': 'BACKGROUND', 'citation': 'Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14.'}, {'pmid': '22322567', 'type': 'BACKGROUND', 'citation': 'Rana OR, Schroder JW, Kuhnen JS, Saygili E, Gemein C, Zink MD, Schauerte P, Schiefer J, Schwinger RH, Weis J, Marx N, Kelm M, Meyer C, Saygili E. The Modified Glasgow Outcome Score for the prediction of outcome in patients after cardiac arrest: a prospective clinical proof of concept study. Clin Res Cardiol. 2012 Jul;101(7):533-43. doi: 10.1007/s00392-012-0423-7. Epub 2012 Feb 10.'}, {'pmid': '23727361', 'type': 'BACKGROUND', 'citation': 'Bouzat P, Suys T, Sala N, Oddo M. Effect of moderate hyperventilation and induced hypertension on cerebral tissue oxygenation after cardiac arrest and therapeutic hypothermia. Resuscitation. 2013 Nov;84(11):1540-5. doi: 10.1016/j.resuscitation.2013.05.014. Epub 2013 May 30.'}]}, 'descriptionModule': {'briefSummary': 'With the repercussion of 55 cases eachyear for 100 000 inhabitants in France, cardio respiratory arrest is a public health issue.\n\nThe 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.\n\nIn 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.\n\nCurrently, the evaluation of the neurological becoming rely on a multimodal clinical and paraclinical approach.\n\nThe 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.\n\nThe 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.\n\nPrincipal criteria of judgement is the percentage of the pupillary light reflex variation measured with Neurolight®, compared between two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both gender\n* Entry in resuscitation after a cardiac arrest intra or extra-hospital\n* Resumption of a spontaneous cardiac activity\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Refusal from patient or his family\n* Age under 18 years\n* Pregnant women\n* Previous neurological damages\n* Persons deprived of liberty by judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT02849561', 'acronym': 'ACR', 'briefTitle': 'Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest : Prospective Study of Routine Care', 'orgStudyIdInfo': {'id': '38RC13.713'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Favourable neurological evolution after cardiac arrest', 'description': 'MGOS 4-5', 'interventionNames': ['Other: Therapeutic hypothermia', 'Device: Synchronized Intermittent Mandatory Ventilation', 'Other: Electroencephalography', 'Device: Pupillary light reflex surveillance', 'Device: Transcranial Doppler']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Unfavourable neurological evolution after cardiac arrest', 'description': 'MGOS 1-3', 'interventionNames': ['Other: Therapeutic hypothermia', 'Device: Synchronized Intermittent Mandatory Ventilation', 'Other: Electroencephalography', 'Device: Pupillary light reflex surveillance', 'Device: Transcranial Doppler']}], 'interventions': [{'name': 'Therapeutic hypothermia', 'type': 'OTHER', 'description': 'With a mattress at 4°C to reach a central temperature at 33,5°C.', 'armGroupLabels': ['Favourable neurological evolution after cardiac arrest', 'Unfavourable neurological evolution after cardiac arrest']}, {'name': 'Synchronized Intermittent Mandatory Ventilation', 'type': 'DEVICE', 'otherNames': ['SIMV'], 'description': 'Constant volume 6 ml/kg', 'armGroupLabels': ['Favourable neurological evolution after cardiac arrest', 'Unfavourable neurological evolution after cardiac arrest']}, {'name': 'Electroencephalography', 'type': 'OTHER', 'otherNames': ['EEG'], 'armGroupLabels': ['Favourable neurological evolution after cardiac arrest', 'Unfavourable neurological evolution after cardiac arrest']}, {'name': 'Pupillary light reflex surveillance', 'type': 'DEVICE', 'description': 'With Neurolight® device.', 'armGroupLabels': ['Favourable neurological evolution after cardiac arrest', 'Unfavourable neurological evolution after cardiac arrest']}, {'name': 'Transcranial Doppler', 'type': 'DEVICE', 'description': 'Monitoring tool for brain hemodynamic evaluation. With Philips HD15 Ultrasound system®.', 'armGroupLabels': ['Favourable neurological evolution after cardiac arrest', 'Unfavourable neurological evolution after cardiac arrest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38700', 'city': 'La Tronche', 'country': 'France', 'facility': 'UniversityHospitalGrenoble', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}], 'overallOfficials': [{'name': 'Michel Durand, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grenoble Hospital University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}