Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-28 @ 8:02 PM
Study NCT ID:
NCT00751634
Status:
COMPLETED
Last Update Posted:
2013-05-06
First Post:
2008-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Temperature Control in Central Fever in the Neuro-ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a-naidech@northwestern.edu', 'phone': '312-503-3335', 'title': 'Dr. Andrew Naidech', 'organization': 'Northwestern University'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group', 'description': 'Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Shivering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group at 0, 1, 2, 6 Hours', 'description': 'Application of the Gaymar Rapr-Round device per approved use'}], 'classes': [{'title': '0 hours', 'categories': [{'measurements': [{'value': '100.8', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '100.3', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '99.9', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '99.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, one, two and six hours after application.', 'description': 'Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.', 'unitOfMeasure': 'degrees F', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time From Start of Cooling Device to Core Temperature < 100.4F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six hours', 'description': 'For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was \\<100.4F', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Severe Shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'six hours', 'description': 'Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall\n\n1. Mild: shivering localized to the neck and/or thorax only\n2. Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax)\n3. Severe: shivering involves gross movements of the trunk and upper and lower extremities', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed for the outcome of BSAS=3'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'six hours', 'description': 'New systolic blood pressure \\< 100 mm Hg, or new vasopressor use during study period', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Arrhythmia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Six hours', 'description': 'New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group', 'description': 'Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group', 'description': 'Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '15.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-30', 'studyFirstSubmitDate': '2008-09-10', 'resultsFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2008-09-10', 'lastUpdatePostDateStruct': {'date': '2013-05-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-13', 'studyFirstPostDateStruct': {'date': '2008-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care', 'timeFrame': 'baseline, one, two and six hours after application.', 'description': 'Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.'}], 'secondaryOutcomes': [{'measure': 'Time From Start of Cooling Device to Core Temperature < 100.4F', 'timeFrame': 'Six hours', 'description': 'For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was \\<100.4F'}, {'measure': 'Number of Participants With Severe Shivering', 'timeFrame': 'six hours', 'description': 'Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall\n\n1. Mild: shivering localized to the neck and/or thorax only\n2. Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax)\n3. Severe: shivering involves gross movements of the trunk and upper and lower extremities'}, {'measure': 'Number of Participants With Hypotension', 'timeFrame': 'six hours', 'description': 'New systolic blood pressure \\< 100 mm Hg, or new vasopressor use during study period'}, {'measure': 'Number of Participants With Arrhythmia', 'timeFrame': 'Six hours', 'description': 'New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['subarachnoid hemorrhage', 'intracerebral hemorrhage', 'fever'], 'conditions': ['Fever', 'Brain Hemorrhage']}, 'descriptionModule': {'briefSummary': 'There are few treatments for central fever (fever that is due to the central nervous system, as opposed to an infectious source). We hypothesize that an externally applied cooling blanket will reduce temperature in neurologically ill patients with central fever.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Two or more days with core temperature ≥ 100.4F\n* Approval of the patient's primary attending physician\n* Need for core temperature measurement independent of the study.\n* Admission to the Neuro-ICU \\[intensive care unit\\] for an underlying condition\n\nExclusion Criteria:\n\n* Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS \\[central nervous system\\] infection or urinary tract infection.\n* Expected death from any cause\n* Known sensitivity to the device\n* History of pre-admission hypothalamic dysfunction or known temperature dysregulation\n* Use of 2 or more vasopressor medications, since this may make a local skin reaction to the device more likely\n* Hemodynamic instability"}, 'identificationModule': {'nctId': 'NCT00751634', 'briefTitle': 'Temperature Control in Central Fever in the Neuro-ICU', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Temperature Control in Central Fever in the Neuro-ICU', 'orgStudyIdInfo': {'id': '1507-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Application of the Gaymar Rapr-Round device per approved use', 'interventionNames': ['Device: Gaymar Rapr-Round (external cooling blanket)']}], 'interventions': [{'name': 'Gaymar Rapr-Round (external cooling blanket)', 'type': 'DEVICE', 'description': 'Application of the device per its approved labeling', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Andrew M Naidech, MD MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gaymar Industries, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrew Naidech', 'investigatorAffiliation': 'Northwestern University'}}}}