Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT00185003
Status:
COMPLETED
Last Update Posted:
2008-10-17
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blockade of Vascular Potassium Channels During Human Endotoxemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019446', 'term': 'Endotoxemia'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004731', 'term': 'Endotoxins'}, {'id': 'D014044', 'term': 'Tolbutamide'}, {'id': 'D019323', 'term': 'omega-N-Methylarginine'}], 'ancestors': [{'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001120', 'term': 'Arginine'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-16', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2008-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamics', 'timeFrame': '24 hrs after LPS administration'}, {'measure': 'Markers of Inflammation', 'timeFrame': '24 hrs after LPS administration'}, {'measure': 'Cytokines', 'timeFrame': '24 hrs after LPS administration'}, {'measure': 'Markers of Renal Injury', 'timeFrame': '24 hrs after LPS administration'}, {'measure': 'Inducible NO synthase expression', 'timeFrame': '24 hrs after LPS administration'}, {'measure': 'NO-metabolites', 'timeFrame': '24 hrs after LPS administration'}, {'measure': 'Mediators of Vascular reactivity', 'timeFrame': '24 hrs after LPS administration'}, {'measure': 'Sensitivity to norepinephrine', 'timeFrame': '24 hrs after LPS administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endotoxemia', 'vascular potassium channels', 'cytokine', 'norepinephrine', 'regional blood flow,', 'inflammation,', 'ion channels,', 'nitric oxide synthase,', 'pharmacology.'], 'conditions': ['Endotoxemia']}, 'referencesModule': {'references': [{'pmid': '16864730', 'type': 'RESULT', 'citation': 'Pickkers P, Dorresteijn MJ, Bouw MP, van der Hoeven JG, Smits P. In vivo evidence for nitric oxide-mediated calcium-activated potassium-channel activation during human endotoxemia. Circulation. 2006 Aug 1;114(5):414-21. doi: 10.1161/CIRCULATIONAHA.105.590232. Epub 2006 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'Background: Activation of NO-synthase and vascular potassium (K) channels may play a role in the sepsis-induced attenuated sensitivity to norepinephrine. We examined whether various K channel blockers and NO-synthase inhibition could restore norepinephrine sensitivity during experimental human endotoxemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n\nExclusion Criteria:\n\n* drug, alcohol, nicotine abuse'}, 'identificationModule': {'nctId': 'NCT00185003', 'briefTitle': 'Blockade of Vascular Potassium Channels During Human Endotoxemia', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Blockade of Vascular Potassium Channels During Human Endotoxemia', 'orgStudyIdInfo': {'id': 'PP02'}, 'secondaryIdInfos': [{'id': 'ZONMW grant 907-00-056'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'endotoxin', 'type': 'DRUG'}, {'name': 'Potassium channel blockers: TEA, Quinin, Tolbutamide', 'type': 'DRUG'}, {'name': 'L-NMMA', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Peter Pickkers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}]}}}