Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-03-18 @ 8:46 AM
Study NCT ID:
NCT02339103
Status:
COMPLETED
Last Update Posted:
2018-11-26
First Post:
2015-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Heat and Intravenous Fluids for Exogenous Rewarming
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-21', 'studyFirstSubmitDate': '2015-01-12', 'studyFirstSubmitQcDate': '2015-01-14', 'lastUpdatePostDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of rewarming', 'timeFrame': '60 minutes', 'description': 'Track to rate of rewarming of each arm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['arteriovenous anastomoses', 'accidental hypothermia', 'rewarming'], 'conditions': ['Hypothermia']}, 'referencesModule': {'references': [{'pmid': '28506514', 'type': 'RESULT', 'citation': 'Christensen ML, Lipman GS, Grahn DA, Shea KM, Einhorn J, Heller HC. A Novel Cooling Method and Comparison of Active Rewarming of Mildly Hypothermic Subjects. Wilderness Environ Med. 2017 Jun;28(2):108-115. doi: 10.1016/j.wem.2017.02.009. Epub 2017 May 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two novel active rewarming techniques in mildly hypothermic people. Volunteers will undergo 3 cooling trials in a circulating bath at 14 degrees celsius and will then be rewarmed with either shivering alone, warmed iv fluids (IVF), or water perfusion pads applied to the hands and feet. The investigators hypothesize that both heated IVF and water perfusion pads to the arteriovenous anastomoses (AVAs) will prove to provide significantly superior rewarming rates than shivering alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any healthy male or female over 18 years of age\n\nExclusion Criteria:\n\n* No heart/blood pressure/cholesterol medications.\n* No history of Raynaud's disease or any other condition (including asthma) that could be aggravated by cold-water immersion"}, 'identificationModule': {'nctId': 'NCT02339103', 'acronym': 'SHIVER', 'briefTitle': 'Study of Heat and Intravenous Fluids for Exogenous Rewarming', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Study of Heat and Intravenous Fluids for Exogenous Rewarming (SHIVER)', 'orgStudyIdInfo': {'id': '31036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Shivering only', 'description': 'Pt placed in sleeping bag and warmed by shivering only'}, {'type': 'EXPERIMENTAL', 'label': 'Warmed IV fluids', 'description': '2 Liter of 42 degree celsius normal saline', 'interventionNames': ['Other: Warmed IV fluids']}, {'type': 'EXPERIMENTAL', 'label': 'Warmed perfusion pads', 'description': 'Warmed perfusion pads placed to palms and soles to rewarm through arteriovenous anastomoses', 'interventionNames': ['Other: Warmed perfusion pads']}], 'interventions': [{'name': 'Warmed IV fluids', 'type': 'OTHER', 'description': '1 Liter of warmed IV fluids at 42 degrees celsius', 'armGroupLabels': ['Warmed IV fluids']}, {'name': 'Warmed perfusion pads', 'type': 'OTHER', 'description': 'Neoprene perfusion pads placed on the palms and soles to rewarm through focusing on the arteriovenous anastomoses', 'armGroupLabels': ['Warmed perfusion pads']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Grant S Lipman', 'investigatorAffiliation': 'Stanford University'}}}}