Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT00150956
Status:
COMPLETED
Last Update Posted:
2005-09-08
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Daily Home Hemodialysis on Circulation, Mental Functions, and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2000-10', 'completionDateStruct': {'date': '2002-01'}, 'lastUpdateSubmitDate': '2005-09-06', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure at 6 months'}, {'measure': 'Cardiac output at 6 months'}, {'measure': 'Extracellular fluid volume at 6 months'}, {'measure': 'Plasma renin activity at 6 months'}, {'measure': 'Muscle sympathetic nerve activity (MSNA) at 6 months'}, {'measure': 'Electroencephalogram (EEG) at 6 months'}, {'measure': 'Neurocognitive functioning at 6 months'}, {'measure': 'Quality of life at 6 months'}], 'secondaryOutcomes': [{'measure': 'Nutritional status at 6 months'}]}, 'conditionsModule': {'conditions': ['End-Stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '9829490', 'type': 'BACKGROUND', 'citation': 'Kooistra MP, Vos J, Koomans HA, Vos PF. Daily home haemodialysis in The Netherlands: effects on metabolic control, haemodynamics, and quality of life. Nephrol Dial Transplant. 1998 Nov;13(11):2853-60. doi: 10.1093/ndt/13.11.2853.'}, {'pmid': '11158871', 'type': 'BACKGROUND', 'citation': 'Vos PF, Zilch O, Kooistra MP. Clinical outcome of daily dialysis. Am J Kidney Dis. 2001 Jan;37(1 Suppl 2):S99-S102. doi: 10.1053/ajkd.2001.20761.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to discover mechanisms responsible for the decrease in (high) blood pressure after starting daily hemodialysis, as has been observed by various investigators. We hypothesized that better control of body water and sodium content and a decline in the autonomic (sympathetic) nervous system activity, increased in chronic renal failure patients, would contribute to improved blood pressure regulation.\n\nMoreover, we studied the effects of daily hemodialysis on mental functions, like information processing and memory, in relation to the previously reported improvement in quality of life, and the effects on nutrition. We hypothesized that all would improve.', 'detailedDescription': 'Although conventional hemodialysis has faced many technical improvements in recent years, a great deal of end-stage renal disease patients, treated with this modality, have suboptimal or high blood pressure, and suffer poor quality of life. Daily hemodialysis has been reported to improve both, but the pathophysiological background is poorly understood.\n\nPatients were studied before and after 6 months of daily (i.e.6 times a week) home hemodialysis, and again after two months of conventional (i.e. thrice weekly) hemodialysis.\n\nWe measured the effects of daily dialysis (compared with conventional dialysis) on blood pressure, cardiac output, extracellular fluid volume, plasma renin activity, sympathetic nervous system activity (through MSNA), the electroencephalogram (EEG), neurocognitive functioning (speed of information processing, memory, executive functioning, and attention), quality of life, and nutritional status'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End-stage renal disease patients\n* Fit and motivated for home hemodialysis\n\nExclusion Criteria:\n\n* Patients, who were treated with frequent dialysis (5 or 6 times a week) before\n* Diabetes mellitus\n* Severe comorbidity (e.g. malignancies)'}, 'identificationModule': {'nctId': 'NCT00150956', 'briefTitle': 'Effects of Daily Home Hemodialysis on Circulation, Mental Functions, and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Study Into the Effects of Daily Home Hemodialysis on Hemodynamics, Neurocognitive Functions, and Quality of Life', 'orgStudyIdInfo': {'id': 'C98-1750'}, 'secondaryIdInfos': [{'id': 'Dutch Kidney Foundation'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Daily home hemodialysis', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC Utrecht, Department of Nephrology & Hypertension', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Pieter F Vos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht, Department of Nephrology & Hypertension'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dianet Dialysis Centers', 'class': 'OTHER'}, {'name': 'Dutch Kidney Foundation', 'class': 'OTHER'}]}}}