Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-01 @ 9:38 AM
Study NCT ID:
NCT02621450
Status:
UNKNOWN
Last Update Posted:
2015-12-10
First Post:
2015-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Sodium Dialysate and Ambulatory Blood Pressure Measurement Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2015-11-21', 'studyFirstSubmitQcDate': '2015-11-30', 'lastUpdatePostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ambulatory blood pressure measurement', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic renal failure', 'hypertension', 'ampulatory blood pressure'], 'conditions': ['Chronic Renal Failure', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '22246593', 'type': 'BACKGROUND', 'citation': 'Gumrukcuoglu HA, Ari E, Akyol A, Akdag S, Simsek H, Sahin M, Gunes Y, Tuncer M. Effects of lowering dialysate sodium on carotid artery atherosclerosis and endothelial dysfunction in maintenance hemodialysis patients. Int Urol Nephrol. 2012 Dec;44(6):1833-9. doi: 10.1007/s11255-011-0117-5. Epub 2012 Jan 14.'}, {'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': 'End stage renal disease (ESRD) is related with increased cardiovascular mortality and morbidity. Hypertension (HT) is an important risk factor for cardiovascular disorder among hemodialysis (HD) patients. The aim of this study going to investigate the effectivity of low-sodium dialysate on the systolic and diastolic blood pressure (BP) levels detected by ABPM and interdialytic weight gain (IDWG) in patients undergoing sustained hemodialysis treatment.\n\nMethods: The study will be included 46 patients who had creatinine clearance levels less than 10 ml/min/1.73 m2 and had been on chronic HD treatment for at least one year. After the enrollment stage, the patients will be allocated low-sodium dialysate or standard-sodium dialysate for six months via computer-generated randomization.', 'detailedDescription': "Patient Selection The present study is a single-center, randomized controlled and double blinded trial. The patients going to enroll for this study had creatinine clearance less than 10 ml/min/1.73 m2 and had been on intermittent HD treatment for at least one year.\n\nThe exclusion criteria for the present study are masking or white coat hypertension, heart failure, cardiomyopathies, acute coronary syndromes, chronic ischemic heart disease, acute or chronic liver disease, endocrine or pulmonary diseases, valvular heart diseases, malignancies, active urinary tract infections, hemoglobin levels below 8 g/dL, and hypotension tendency.\n\nSixty-four patients going to enroll for eligibility and after the initial assessment. Clinic and laboratory profiles of the patients including cause of renal disease, history of HT and antihypertensive treatments going to record by systematic review of the patient files. After the enrollment stage, the patients going to allocate low-sodium dialysate or standard sodium dialysate for 6 months via computer-generated randomization.\n\nThey going to dialyze three times a week with synthetic polysulfone (Hollow-fiber, Low Flux, KUF\\<20, 1.6 m2) membrane, each session lasting 4 hours with bicarbonate dialysate (with 33mmol/L concentration) and 300-350 ml/min blood-flow. .\n\nStudy protocol All patients going to assess before and 6 months after the study. Before initiating the study, all patients were dialyzed with 140 mEq/L sodium concentration. In the low-sodium dialysate group, the dialysate sodium concentration going to reduce from 140 to 137mEq/L. To eliminate the acute effects of hemodialysis on the parameters measured, baseline and end-of-study measurements going to perform in non-dialysis day, 24 hours after the mid-week session.\n\nAmbulatory blood pressure measurement Ambulatory BP measurement during 24-hour going to perform using a Space Labs 90207 oscillometric method (Redmond, Washington, USA). The BP measurements going to perform automatically from non-fistula arm. The confirmation of the device going to check with the standard auscultator method in order to ensure that the changes in BP values between the two methods did not exceed +5 mm Hg.\n\nThe device going to set to achieve BP evaluation at 30-minute intervals during the night (11:00 PM to 07:00 AM) and at 20-minute intervals during the day (07:00 AM to 11:00 PM).\n\n''Nocturnal dipping'' going to define as a decrease of greater than 10% (when compared with the daytime values) in the systolic or diastolic blood pressure at night. ''Non-nocturnal dipping'' going to define as a decrease of less than 10% (when compared with the daytime values) in the blood pressure parameters levels at night or did not decrease in the systolic or diastolic blood pressure at night"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe patients with creatinine clearance less than 10 ml/min/1.73 m2 and under intermittent HD treatment for at least one year are included into the study.\n\nExclusion Criteria as follows:\n\nMasking or white coat hypertension, heart failure, cardiomyopathies, acute coronary syndromes, chronic ischemic heart disease, acute or chronic liver disease, endocrine or pulmonary diseases, valvular heart diseases, malignancies, active urinary tract infections, hemoglobin levels below 8 g/dL, and hypotension tendency -'}, 'identificationModule': {'nctId': 'NCT02621450', 'briefTitle': 'Low Sodium Dialysate and Ambulatory Blood Pressure Measurement Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'The Effect of Low Sodium Dialysate on Ambulatory Blood Pressure Measurement Parameters in Patients Undergoing Hemodialysis', 'orgStudyIdInfo': {'id': '2012-51'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'standart dialysate', 'description': 'dialysate sodium 140 mEq/L', 'interventionNames': ['Biological: standart dialysis']}, {'type': 'OTHER', 'label': 'low sodium dialysate', 'description': 'dialysate sodium will be reduced from 140 mEq/L to 137 mEq/L', 'interventionNames': ['Biological: low sodium dialysis']}], 'interventions': [{'name': 'standart dialysis', 'type': 'BIOLOGICAL', 'description': 'dialysate sodium consentration 140 mEq', 'armGroupLabels': ['standart dialysate']}, {'name': 'low sodium dialysis', 'type': 'BIOLOGICAL', 'description': 'dialysate sodium consentration will be reducer from 140 mEq to 137 mEq', 'armGroupLabels': ['low sodium dialysate']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'hasan ali gümrükçüoğlu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yuzuncu Yil Univesty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associated professor', 'investigatorFullName': 'Hasan ali gümrükçüoğlu', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}