Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-05 @ 5:59 PM
Study NCT ID:
NCT00714766
Status:
COMPLETED
Last Update Posted:
2009-02-16
First Post:
2008-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heat Stress and Volume Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013575', 'term': 'Syncope'}], 'ancestors': [{'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-13', 'studyFirstSubmitDate': '2008-07-10', 'studyFirstSubmitQcDate': '2008-07-10', 'lastUpdatePostDateStruct': {'date': '2009-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac filling pressure in relation to cardiac SV', 'timeFrame': 'with varying degress of lower body negative pressures'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Syncope']}, 'descriptionModule': {'briefSummary': 'Heat stress reduces the central blood volume and causes orthostatic intolerance. The hypothesis is that infusion of volume may reduce effects of orthostatic stress during heat stress.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 \\< 40\n\nExclusion Criteria:\n\n* Abnormal medical history'}, 'identificationModule': {'nctId': 'NCT00714766', 'briefTitle': 'Heat Stress and Volume Administration', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Heat Stress and Volume Administration', 'orgStudyIdInfo': {'id': 'Heat stress RH08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Procedure: Intravascular volume administration']}], 'interventions': [{'name': 'Intravascular volume administration', 'type': 'PROCEDURE', 'description': 'Infusion of colloid to reestablish CVP under heat stress', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Dept of anesthesiology 2041', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Niels Secher, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Niels Secher, Professor', 'oldOrganization': 'Righospitale'}}}}