Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-04-08 @ 4:47 PM
Study NCT ID:
NCT02145260
Status:
COMPLETED
Last Update Posted:
2022-10-31
First Post:
2014-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fmccausland@bwh.harvard.edu', 'phone': '6177326432', 'title': 'Finnian Mc Causland', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From randomization to maximum of 6 inpatient study sessions (two-week period)', 'eventGroups': [{'id': 'EG000', 'title': 'Lower Dialysate Sodium', 'description': 'Dialysate sodium concentration of 138 mmol/L\n\nLower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate): A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 28, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Higher Dialysate Sodium', 'description': 'Dialysate sodium concentration of 142 mmol/L\n\nHigher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate): A higher dialysate sodium will be used in the experimental arm (142 mmol/L)', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 24, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension (>180 mmHg)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain/myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'NSTEMI non-ST segment elevation myocardial infarction', 'notes': 'NSTEMI non-ST segment elevation myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'post-operative bleed', 'notes': 'Post-operative bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Intra-dialytic Decline in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Dialysate Sodium', 'description': 'Dialysate sodium concentration of 138 mmol/L\n\nLower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate): A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)'}, {'id': 'OG001', 'title': 'Higher Dialysate Sodium', 'description': 'Dialysate sodium concentration of 142 mmol/L\n\nHigher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate): A higher dialysate sodium will be used in the experimental arm (142 mmol/L)'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '16', 'groupId': 'OG000'}, {'value': '23', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average decline in systolic blood pressure will be measured up to a maximum of six inpatient HD sessions, occurring over a two-week time period', 'description': 'Pre-dialysis SBP minus lowest intra-dialytic SBP. The data table reflect the change in systolic blood pressured (SBP) assessed at up to 6 HD sessions, where the change for each session was calculated as the pre-SBP minus the lowest SBP (during the session), and the change values from the multiple sessions were then averaged for a participant.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Pre-dialysis High-sensitivity Troponin I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Dialysate Sodium', 'description': 'Dialysate sodium concentration of 138 mmol/L\n\nLower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate): A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)'}, {'id': 'OG001', 'title': 'Higher Dialysate Sodium', 'description': 'Dialysate sodium concentration of 142 mmol/L\n\nHigher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate): A higher dialysate sodium will be used in the experimental arm (142 mmol/L)'}], 'timeFrame': 'The change in pre-dialysis high sensitivity troponin I concentrations will be measured between the first and second inpatient hemodialysis sessions, occuring over a period of three days', 'description': 'Cardiac injury biomarkers', 'reportingStatus': 'POSTED', 'populationDescription': 'No measured due to sample storage issues'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lower Dialysate Sodium', 'description': 'Dialysate sodium concentration of 138 mmol/L\n\nLower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate): A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)'}, {'id': 'FG001', 'title': 'Higher Dialysate Sodium', 'description': 'Dialysate sodium concentration of 142 mmol/L\n\nHigher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate): A higher dialysate sodium will be used in the experimental arm (142 mmol/L)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Started', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'comment': 'Completed follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '3 patients in the lower dialysate sodium arm and 2 patients in the higher dialysate sodium arm were discharged prior to the first study session.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lower Dialysate Sodium', 'description': 'Dialysate sodium concentration of 138 mmol/L\n\nLower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate): A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)'}, {'id': 'BG001', 'title': 'Higher Dialysate Sodium', 'description': 'Dialysate sodium concentration of 142 mmol/L\n\nHigher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate): A higher dialysate sodium will be used in the experimental arm (142 mmol/L)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '14', 'groupId': 'BG000'}, {'value': '58', 'spread': '15', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '14.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-01', 'size': 319077, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-09T21:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-02', 'studyFirstSubmitDate': '2014-05-13', 'resultsFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2014-05-21', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-02', 'studyFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Intra-dialytic Decline in Systolic Blood Pressure', 'timeFrame': 'Average decline in systolic blood pressure will be measured up to a maximum of six inpatient HD sessions, occurring over a two-week time period', 'description': 'Pre-dialysis SBP minus lowest intra-dialytic SBP. The data table reflect the change in systolic blood pressured (SBP) assessed at up to 6 HD sessions, where the change for each session was calculated as the pre-SBP minus the lowest SBP (during the session), and the change values from the multiple sessions were then averaged for a participant.'}], 'secondaryOutcomes': [{'measure': 'Change in Pre-dialysis High-sensitivity Troponin I', 'timeFrame': 'The change in pre-dialysis high sensitivity troponin I concentrations will be measured between the first and second inpatient hemodialysis sessions, occuring over a period of three days', 'description': 'Cardiac injury biomarkers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Hypotension', 'Hospitalization'], 'conditions': ['Intra-dialytic Hypotension']}, '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': 'Intra-dialytic hypotensive (IDH) events can be defined as an abrupt decline in blood pressure that cause symptoms and/or require an intervention. They are common, affecting up to one third of maintenance HD sessions. Detrimental associations include: development of myocardial stunning, cerebral hypo-perfusion, vascular access thrombosis and greater mortality.\n\nRapid solute removal by HD generates temporary osmotic gradients between the intra-vascular and intra-cellular compartments, promoting trans-cellular fluid movement and resultant hypotension. Manipulation of osmotic gradients, e.g. using higher dialysate sodium (DNa), may ameliorate excess SBP decline during HD.\n\nThis study aims to assess the effects of higher (142 mmol/L) versus lower (138 mmol/L) dialysate sodium (DNa) use in adult chronic hemodialysis patients admitted to hospital on intra-dialytic blood pressure and biomarkers of cardiac ischemia.\n\nThe investigators will randomly assign subjects to higher versus lower DNa during their hospital stay, up to a maximum of six HD sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic HD (\\>90 days)\n* Age ≥18y\n* Informed consent\n* First admission during study period.\n\nExclusion Criteria:\n\n* Use of pressors\n* Pre-dialysis serum sodium \\<=128mmol/L or \\> 145 mmol/L\n* Pre-dialysis SBP \\>180 mmHg\n* Intensive care stay earlier in admission\n* Expected length of stay \\<24 hours (e.g. admission for HD access procedure)\n* Acute coronary syndrome within seven days\n* Acute stroke\n* Institutionalized individuals\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02145260', 'briefTitle': 'Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients', 'orgStudyIdInfo': {'id': '2014P000629'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lower dialysate sodium', 'description': 'Dialysate sodium concentration of 138 mmol/L', 'interventionNames': ['Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)']}, {'type': 'EXPERIMENTAL', 'label': 'Higher dialysate sodium', 'description': 'Dialysate sodium concentration of 142 mmol/L', 'interventionNames': ['Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)']}], 'interventions': [{'name': 'Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)', 'type': 'DRUG', 'description': 'A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)', 'armGroupLabels': ['Lower dialysate sodium']}, {'name': 'Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)', 'type': 'DRUG', 'description': 'A higher dialysate sodium will be used in the experimental arm (142 mmol/L)', 'armGroupLabels': ['Higher dialysate sodium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Finnian Mc Causland, MB, MMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine, Harvard Medical School', 'investigatorFullName': 'Finnian McCausland', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}