Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT00332267
Status:
COMPLETED
Last Update Posted:
2008-09-04
First Post:
2006-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D019446', 'term': 'Endotoxemia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D000532', 'term': 'Altitude Sickness'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-02', 'studyFirstSubmitDate': '2006-05-31', 'studyFirstSubmitQcDate': '2006-05-31', 'lastUpdatePostDateStruct': {'date': '2008-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral blood flow', 'timeFrame': '0, 9 hours'}, {'measure': 'Cerebral oxygen metabolism', 'timeFrame': '0, 9 hours'}, {'measure': 'Plasma cytokine content', 'timeFrame': '0, 4, 19, 12 hours'}, {'measure': 'Lake Louise Score', 'timeFrame': '0, 4, 9, 12 hours'}, {'measure': 'ESQ-C', 'timeFrame': '0, 4, 9, 12 hours'}, {'measure': 'Endotoxemia Score', 'timeFrame': '0, 4, 9, 12 hours'}], 'secondaryOutcomes': [{'measure': 'Cerebral net flux', 'timeFrame': '0, 9 hours'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'Hourly, 0 through 12 hours'}, {'measure': 'Heart rate', 'timeFrame': 'Hourly, 0 through 12 hours'}, {'measure': 'Oxygen saturation', 'timeFrame': 'Hourly, 0 through 12 hours'}, {'measure': 'Body temperature', 'timeFrame': 'Hourly, 0 through 12 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Hypoxia', 'Altitude Sickness', 'Endotoxin', 'Cytokines', 'Cerebral blood flow', 'Cerebral metabolism', 'Reactive oxygen species'], 'conditions': ['Hypoxia', 'Endotoxemia', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of the present protocol is to study whether a low level of oxygen in the blood will affect the immune response to as well as cerebral blood flow and metabolism during an infection and, conversely, whether the acute systemic and cerebral physiologic response to hypoxia is modified by an ongoing inflammatory response.', 'detailedDescription': 'The combination of acute infection and a low level of oxygen in the blood is a common phenomenon. Thus, acute hypoxia may complicate severe infections including severe sepsis. Conversely, healthy persons who ascend to moderately high altitudes, which will be associated with a lowering of the inspired oxygen level, may sustain an infection. Even so, it is unknown whether hypoxia modifies the systemic inflammatory response, or, conversely, whether the reaction to hypoxia is influenced by the presence of systemic inflammation. The present protocol aims to measure global cerebral blood flow, metabolism and net flux as well as the systemic response in healthy volunteers who are subjected to either normobaric hypoxia alone (N=12), low-dose IV endotoxin infusion alone (N=12), or a combination of endotoxin infusion and normobaric hypoxia (N=12).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy nonsmoking male\n* Age 18-45 yrs\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT00332267', 'briefTitle': 'Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia', 'orgStudyIdInfo': {'id': 'KM-HYP/ETX'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endotoxin infusion, Normobaric hypoxia', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Center of Inflammation and Metabolism, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Sarah Taudorf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Kirsten Moller, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Ministry of Science, Technology and Innovation, Denmark', 'class': 'OTHER_GOV'}, {'name': 'H:S, Denmark', 'class': 'UNKNOWN'}, {'name': 'The Danish National Research Foundation, Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Kirsten Moller', 'oldOrganization': 'Rigshospitalet'}}}}