Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-03-10 @ 11:51 PM
Study NCT ID:
NCT01311167
Status:
TERMINATED
Last Update Posted:
2013-04-18
First Post:
2011-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Recruitment problems (not enough patients were found who met eligibility criteria)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-17', 'studyFirstSubmitDate': '2011-03-07', 'studyFirstSubmitQcDate': '2011-03-08', 'lastUpdatePostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily sodium excretion of sodium in the urine', 'timeFrame': '4 days'}], 'secondaryOutcomes': [{'measure': 'Daily potassium excretion', 'timeFrame': '4 days'}, {'measure': 'weight reduction', 'timeFrame': '4 days'}, {'measure': 'Reduction of doses of diuretics', 'timeFrame': '4 days'}, {'measure': 'Reduction of ascites', 'timeFrame': '4 days'}, {'measure': 'Reduction of cortisol excretion in the urine', 'timeFrame': '4 days'}, {'measure': 'Reduction of cortisol levels in the urine', 'timeFrame': '4 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dexamethasone', 'Sodium'], 'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Accumulation of salt and water in patients with liver disease (so called liver cirrhosis) is possibly related to the increased effect of steroid hormones on salt reabsorption in the kidney. By reducing overall steroid production with the dexamethasone the accumulation of salt and water could be prevented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with established liver cirrhosis (biopsy or biochemically)\n* hepatorenal syndrome type 1 or 2 (with a serum creatinin \\>175 umol/l)\n* age between 18 and 75\n* no bacterial infection\n* no cardiovascular or extrahepatic disease (end of life)\n* no structural kidney disease\n* no hepatocellular carcinoma\n\nExclusion Criteria:\n\n* age under 15 or over 75\n* treatment with corticosteroids (dexamethasone included)\n* bacterial infection\n* cardiovascular or extrahepatic disease (end of life)\n* structural kidney disease (indicated by hematuria, proteinuria)\n* hepatocellular carcinoma\n* mental disability'}, 'identificationModule': {'nctId': 'NCT01311167', 'briefTitle': 'Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Prospective Randomized Double Blind Placebo Controlled Intervention Study of the Effect of Dexamethasone on the Sodium Retention in Patients With Liver Cirrhosis', 'orgStudyIdInfo': {'id': 'Dexa_Cirr_2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Daily administration of 2 mg of dexamethasone for 4 days', 'armGroupLabels': ['Dexamethasone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Daily administration of 2 mg of placebo for 4 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'University Hospital Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'University Hospital Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'University Hospital Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Geneva', 'class': 'OTHER'}, {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'National Center of Competence Kidney.CH', 'oldOrganization': 'Swiss National Foundation'}}}}