Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT00825318
Status:
COMPLETED
Last Update Posted:
2014-05-26
First Post:
2009-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014462', 'term': 'Ultrafiltration'}], 'ancestors': [{'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005374', 'term': 'Filtration'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JaJones@chpnet.org', 'phone': '2125233530', 'title': 'James Jones, MD', 'organization': "St. Luke's-Roosevelt Hospital Center"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Prestudy Phase', 'description': 'During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Daily Ultrafiltration Phase', 'description': 'During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Return Phase', 'description': 'During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Elevated Potassium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Elevated Glucose Level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Arterial Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy Phase', 'description': 'During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.'}, {'id': 'OG001', 'title': 'Daily Ultrafiltration Phase', 'description': 'During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.'}, {'id': 'OG002', 'title': 'Return Phase', 'description': 'During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '133'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '84', 'upperLimit': '111'}, {'value': '106', 'groupId': 'OG002', 'lowerLimit': '92', 'upperLimit': '121'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Daily Ultrafiltration', 'description': 'During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Daily Ultrafiltration', 'description': 'During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.6', 'spread': '8.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-28', 'studyFirstSubmitDate': '2009-01-16', 'resultsFirstSubmitDate': '2014-02-18', 'studyFirstSubmitQcDate': '2009-01-19', 'lastUpdatePostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-28', 'studyFirstPostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Arterial Blood Pressure', 'timeFrame': 'Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['End-stage renal disease', 'Chronic kidney disease', 'Hemodialysis'], 'conditions': ['End-stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '3727139', 'type': 'RESULT', 'citation': 'Bytzer P. [Laxative abuse]. Ugeskr Laeger. 1986 Jun 2;148(23):1387-9. No abstract available. Danish.'}]}, 'descriptionModule': {'briefSummary': "In this study, the researchers want to find out how patients who have ultrafiltration (removal of excess fluid) 6 times a week and twice-weekly dialysis (removal of excess fluid and waste products) do in terms of their blood pressure and weight. The researchers believe that maintaining patients at their estimated target weight throughout the week using daily ultrafiltration will reduce their blood pressure to levels shown in other similar studies. Such a reduction in blood pressure may reduce the incidence of cerebral vascular disease, peripheral vascular disease, coronary artery disease, and congestive heart failure. The researchers also believe that patients' quality of life will improve while they are undergoing daily ultrafiltration.\n\nStudies show that more frequent dialysis treatments result in fewer symptoms for patients. The patients feel better and avoid the weight gains and symptoms that patients have on three times a week dialysis. In addition, their blood lab results are better controlled, requiring less medication."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years and less than or equal to 80 years\n* Stable three treatments per week dialysis schedule for at least three months prior to beginning the study\n* Residual renal clearance \\<1.5ml/min per 35L of urea volume\n* Pre-dialysis serum sodium levels of greater than 136 mEq/L\n\nExclusion Criteria:\n\n* Non-compliance with hemodialysis treatments--defined as missing more than 1 treatment over the 3 month period prior to the study\n* Unable to verbally communicate in English or Spanish\n* Current requirement for hemodialysis more than three times per week due to medical comorbidity (including fourth session for ultrafiltration)\n* Currently on daily or nocturnal hemodialysis, or less than 3 months since discontinued such treatment\n* Expected geographic unavailability at dialysis center during any phase of the trial\n* Less than 3 months since the patient returned after acute rejection resulting in allograft failure\n* Currently in acute care or chronic care hospital\n* Pregnancy\n* Current involvement in any non-observational trial\n* Unable or unwilling to follow the study protocol for any reason (including mental incompetence)\n* Unable or unwilling to provide informed consent or sign IRB-approved consent form\n* Pace maker, implantable pump, artificial joint\n* Amputation of a limb'}, 'identificationModule': {'nctId': 'NCT00825318', 'briefTitle': 'Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Renal Research Institute'}, 'officialTitle': 'Pilot Trial To Study Blood Pressure, Weight and Hydration State in Patients Undergoing A Treatment Regimen of Daily Ultrafiltration and Twice-weekly Hemodialysis As Compared to Conventional Three Times Per Week Hemodialysis', 'orgStudyIdInfo': {'id': '004-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daily ultrafiltration', 'description': 'During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.', 'interventionNames': ['Procedure: Ultrafiltration']}], 'interventions': [{'name': 'Ultrafiltration', 'type': 'PROCEDURE', 'description': 'Frequency of ultrafiltration is increased from the conventional 3 times a week to 6 times a week.', 'armGroupLabels': ['Daily ultrafiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Irving Place Dialysis Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Upper Manhattan Dialysis Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Yorkville Dialysis Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Nathan W Levin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renal Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renal Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vizio Medical Devices', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}