Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT00263302
Status:
SUSPENDED
Last Update Posted:
2008-07-04
First Post:
2005-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diuretic Efficacy of Dexamethasone in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-01', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2008-07-02', 'studyFirstSubmitDate': '2005-12-07', 'studyFirstSubmitQcDate': '2005-12-07', 'lastUpdatePostDateStruct': {'date': '2008-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urine volume'}, {'measure': 'urine electrolyte excretion (urine sodium, urine potassium, urine chloride), and urine creatinine.'}, {'measure': 'serum electrolyte (serum sodium, serum potassium, serum chloride), serum creatinine, serum urea, serum uric Acid.'}, {'measure': 'fractional sodium excretion'}, {'measure': 'glomerular filtration rate (calculated by Cockroft and Gault formula).'}]}, 'conditionsModule': {'keywords': ['dexamethasone, diuretic, congestive heart failure'], 'conditions': ['Heart Failure, Congestive']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether glucocorticoids have potent diuretic effects in patients with congestive heart failure.', 'detailedDescription': 'Glucocorticoids are known to have pronounced physiological effects in the kidney. Conventional teaching dictates that it should be used with caution in patients with congestive heart failure due to its fluid and sodium retention effects. Surprisingly, despite the widespread prevalence of this belief within the medical community, there are few data to support it. In fact, several small animal studies have documented its striking diuretic effects due to increased renal plasma flow and glomerular filtration rate without changes in the glomerular filtration fraction. We design this study to determine whether glucocorticoids have a potent diuretic effect in patients with heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Congestive heart failure patients due to any cause\n* Patients with normal cortical function\n* Congestive heart failure patients who are on diuretic therapy\n* Clinically stable and body weight maintained the same for at least 3 days without signs of fluid retention\n\nExclusion Criteria:\n\n* Patient refusal\n* Signs of infection'}, 'identificationModule': {'nctId': 'NCT00263302', 'briefTitle': 'Diuretic Efficacy of Dexamethasone in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University'}, 'officialTitle': 'Diuretic Efficacy of Dexamethasone in Congestive Heart Failure Patients', 'orgStudyIdInfo': {'id': '0512-e'}}, 'armsInterventionsModule': {'interventions': [{'name': 'dexamethasone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '050031', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Kunshen Liu', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '050031', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}], 'overallOfficials': [{'name': 'Kunshen Liu, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hebei Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University', 'class': 'OTHER'}}}}