Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-02 @ 11:37 PM
Study NCT ID:
NCT02098356
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2014-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of High Versus Low Bicarbonate Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D000138', 'term': 'Acidosis'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-05-02', 'size': 246468, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-04-26T12:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-01', 'studyFirstSubmitDate': '2014-03-24', 'studyFirstSubmitQcDate': '2014-03-25', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-dialysis serum bicarbonate', 'timeFrame': '5 weeks', 'description': 'Change in predialysis bicarbonate'}], 'secondaryOutcomes': [{'measure': 'serum beta-hydroxybutyrate', 'timeFrame': '5 weeks', 'description': 'Change in beta-hydroxybutyrate during dialysis'}, {'measure': 'beta-hydroxybutyrate clearance', 'timeFrame': '5 weeks', 'description': 'Change in clearance between different dialysates'}, {'measure': 'interleukin-6', 'timeFrame': '5 weeks', 'description': 'Change during dialysis'}, {'measure': 'serum free fatty acids', 'timeFrame': '5 weeks', 'description': 'Change during dialysis'}, {'measure': 'Time to recover from dialysis', 'timeFrame': '5 weeks', 'description': 'Change between dialysates'}, {'measure': 'Dialysis symptom questionnaire', 'timeFrame': '5 weeks', 'description': 'Change between dialysates'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hemodialysis', 'dialysis', 'acidosis', 'bicarbonate'], 'conditions': ['Chronic Kidney Disease', 'End-stage Renal Disease', 'Metabolic Acidosis']}, 'descriptionModule': {'briefSummary': 'This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens.', 'detailedDescription': 'This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens. These parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as part of usual care. They will then be switched to a lower bicarbonate prescription, after which these parameters will be reassessed. The study will also examine changes in inflammatory markers, glycemic control, ketogenesis, and lipolysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18\n* Receiving chronic thrice-weekly conventional hemodialysis for at least 6 months\n\nExclusion Criteria:\n\n* Use of oral alkali within the previous month\n* Hospitalization within the previous month\n* Inability to provide written informed consent\n* Plans for kidney transplant in the next 2 months\n* Planned change in phosphate binder therapy within the next month\n* Pregnancy, or planned pregnancy in the next 2 months'}, 'identificationModule': {'nctId': 'NCT02098356', 'briefTitle': 'Comparison of High Versus Low Bicarbonate Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis', 'orgStudyIdInfo': {'id': '2012-480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low bicarbonate', 'description': 'Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate', 'interventionNames': ['Other: Low Bicarbonate']}], 'interventions': [{'name': 'Low Bicarbonate', 'type': 'OTHER', 'description': 'Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate', 'armGroupLabels': ['Low bicarbonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Matthew Abramowitz, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Matthew Abramowitz', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}