Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-24 @ 3:36 AM
Study NCT ID:
NCT01980251
Status:
COMPLETED
Last Update Posted:
2016-08-04
First Post:
2013-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delirium, Electroencephalographic Alterations and Cortical Spreading Depression (CSD) in Critical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, cerebrospinalfluid, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2013-10-24', 'studyFirstSubmitQcDate': '2013-11-04', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparing electroencephalographic and electrocortical recordings in neurointensive care', 'timeFrame': 'Delirium - a clinical manifestation of cortical spreading depression?'}], 'primaryOutcomes': [{'measure': 'The occurence of electroencephalographic alterations and potential electroencephalographic signatures prior to and during delirium in the ICU', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'The occurence of cortical spreading depression in noninvasive direct current-EEG in critically ill patients without acute cerebral trauma', 'timeFrame': 'Cortical spreading depression in the ICU'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Delirium, electroencephalography, CSD'], 'conditions': ['Delirium']}, 'referencesModule': {'references': [{'pmid': '30891696', 'type': 'DERIVED', 'citation': 'Nielsen RM, Urdanibia-Centelles O, Vedel-Larsen E, Thomsen KJ, Moller K, Olsen KS, Lauritsen AO, Eddelien HS, Lauritzen M, Benedek K. Continuous EEG Monitoring in a Consecutive Patient Cohort with Sepsis and Delirium. Neurocrit Care. 2020 Feb;32(1):121-130. doi: 10.1007/s12028-019-00703-w.'}]}, 'descriptionModule': {'briefSummary': 'Delirium in the intensive care unit is an acutely developed brain dysfunction affecting up to 80 % of patients. It is associated with significantly increased morbidity and mortality during admission and post-discharge. The mechanism behind the condition is poorly understood but assumably multifactorial, and the purpose of this study is to investigate the pathophysiology further.', 'detailedDescription': 'The pathophysiology behind delirium in critical illness is not clarified but assumed to involve inflammation, changes in cerebral perfusion and neurotransmission, sleep deprivation and the use of i.e. sedatives.\n\nCortical spreading depression is a phenomenon occuring in critically ill patients with acute cerebral trauma and likely associated with significant secondary neuron damage.\n\nThe hypothesis is that\n\n1. Delirium in critically ill patients without acute cerebral damage is a clinical manifestation of cortical spreading depression and can be recorded in a noninvasive direct current-electroencephalography\n2. Electroencephalographic alterations or potentially specific signatures occur in delirium and thus, delirium can be predicted by recording continuous alternate current electroencephalography on admission in an ICU'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients with and without acute cerebral trauma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* expected admission in the ICU \\>24 hours\n\nExclusion Criteria:\n\n* Cerebral trauma \\<6 months\n* existing delirium\n* severe dementia'}, 'identificationModule': {'nctId': 'NCT01980251', 'briefTitle': 'Delirium, Electroencephalographic Alterations and Cortical Spreading Depression (CSD) in Critical Illness', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Delirium, Electroencephalographic Alterations and Cortical Spreading Depression in Critical Illness', 'orgStudyIdInfo': {'id': 'Delirium and cEEG'}}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Glostrup Hospital, University of Copenhagen', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Kirsten Moller, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Neuroanaesthesiology 2093, Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data analysis is in progress'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Rikke Malte Nielsen, M.D.', 'investigatorAffiliation': 'Glostrup University Hospital, Copenhagen'}}}}