Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT00724633
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2008-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-02', 'studyFirstSubmitDate': '2008-07-25', 'studyFirstSubmitQcDate': '2008-07-28', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ambulatory blood pressure', 'timeFrame': '3 months', 'description': 'Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study'}], 'secondaryOutcomes': [{'measure': 'thirst', 'timeFrame': '3 months'}, {'measure': 'QOL Scores (KDQOL, mins to recovery)', 'timeFrame': '3 months'}, {'measure': 'intradialytic hypotension rate, intradialytic symptoms', 'timeFrame': '3 months'}, {'measure': 'mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dialysate', 'sodium', 'hemodialysis', 'blood pressure', 'thirst', 'intradialytic symptoms', 'interdialytic weight gain', 'extracellular fluid balance', 'mechanisms'], 'conditions': ['Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '39498822', 'type': 'DERIVED', 'citation': 'Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Patients currently receiving hemodialysis will be randomized to receive 1 of 3 dialysate sodium prescriptions. The effects on blood pressure, interdialytic weight gain, thirst, and intradialytic symptoms will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients on 3 times weekly hemodialysis of at least 3 months\n* elevated average ambulatory blood pressures\n* current dialysate sodium prescription 140mEq/L\n* average pre-dialysis serum sodium \\<140mEq/L\n\nExclusion Criteria:\n\n* frequent intradialytic hypotension\n* estimated life expectancy \\<1 year\n* non-adherence to dialysis prescription\n* pregnancy\n* inability or unwillingness to complete study measures'}, 'identificationModule': {'nctId': 'NCT00724633', 'briefTitle': 'Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'R-08-252'}, 'secondaryIdInfos': [{'id': '15153'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'standard dialysate Na 140 mEq/L', 'interventionNames': ['Other: Lowering the dialysate sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': "dialysate sodium equal to patient's predialysis serum Na", 'interventionNames': ['Other: Lowering the dialysate sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': "dialysate sodium lower than patient's predialysis plasma sodium", 'interventionNames': ['Other: Lowering the dialysate sodium']}], 'interventions': [{'name': 'Lowering the dialysate sodium', 'type': 'OTHER', 'description': 'Please see above', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4G5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Center', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Rita Suri, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}