Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT01267760
Status:
COMPLETED
Last Update Posted:
2013-07-09
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Biochemical Effects of Multipass Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014511', 'term': 'Uremia'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003956', 'term': 'Dialysis'}, {'id': 'D006435', 'term': 'Renal Dialysis'}], 'ancestors': [{'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-06', 'studyFirstSubmitDate': '2010-01-26', 'studyFirstSubmitQcDate': '2010-12-27', 'lastUpdatePostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urea Kt/V', 'timeFrame': '9 hours'}], 'secondaryOutcomes': [{'measure': 'Creatinine clearance', 'timeFrame': '9 hours'}, {'measure': 'Patient symptoms', 'timeFrame': '9 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dialysis', 'hemodialysis', 'Effect of recycled low-volume dialysate on dialysis efficacy'], 'conditions': ['Uremia']}, 'referencesModule': {'references': [{'pmid': '23136214', 'type': 'RESULT', 'citation': 'Heaf JG, Axelsen M, Pedersen RS. Multipass haemodialysis: a novel dialysis modality. Nephrol Dial Transplant. 2013 May;28(5):1255-64. doi: 10.1093/ndt/gfs484. Epub 2012 Nov 7.'}, {'pmid': '25896788', 'type': 'DERIVED', 'citation': 'Eloot S, Van Biesen W, Axelsen M, Glorieux G, Pedersen RS, Heaf JG. Protein-bound solute removal during extended multipass versus standard hemodialysis. BMC Nephrol. 2015 Apr 18;16:57. doi: 10.1186/s12882-015-0056-y.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether recycled dialysis fluid can supply enough clearance for hemodiaysis patients.', 'detailedDescription': 'Conventional hemodialysis uses large amounts of water, which hinders travel possibilies for home hemodialysis (HD) patients. We have developed a recycling system using 25-30 l dialysate per dialysis. In vitro investigations show that this results in adequate dialysis.\n\n12 HD patients will be studied during two dialysis sessions. The first HD will be a conventional 4 hour dialysis, using single pass dialysate. The second will be an 8-hour HD using multipass (recycled) dialysate 25-30 l. Clearance of urea, creatinine, phosphate and cobalamin will be measured both in the patient and the dialysate. Patient symptoms will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable chronic HD patients\n* Informed consent\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Psychiatric disease'}, 'identificationModule': {'nctId': 'NCT01267760', 'acronym': 'MHD', 'briefTitle': 'Clinical and Biochemical Effects of Multipass Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Clinical and Biochemical Effects of Multipass Hemodialysis', 'orgStudyIdInfo': {'id': 'mhd1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional HD', 'description': 'conventional 4-hour HD', 'interventionNames': ['Device: Multipass hemodialysis']}], 'interventions': [{'name': 'Multipass hemodialysis', 'type': 'DEVICE', 'otherNames': ['dialysis', 'hemodialysis', 'dialysate'], 'description': '8-hour dialysis using a recycled dialysis bath of 25-30 l', 'armGroupLabels': ['conventional HD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2880', 'city': 'Herlev', 'state': 'Denmark', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'James G Heaf, MD DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Flexdialysis ApS', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'James heaf', 'investigatorAffiliation': 'Herlev Hospital'}}}}