Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-03 @ 10:02 PM
Study NCT ID:
NCT03943212
Status:
COMPLETED
Last Update Posted:
2019-05-09
First Post:
2019-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D005221', 'term': 'Fatigue'}], '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': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel-Group, Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-07', 'studyFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2019-05-07', 'lastUpdatePostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dialysis Recovery Time', 'timeFrame': '4 weeks', 'description': 'Mean difference in change in Dialysis Recovery Time between the Blood Flow Rate Reduction group and the Control group. Dialysis recovery time is measured by asking the question, "How long did it take you to recover from dialysis?"'}], 'secondaryOutcomes': [{'measure': 'London Evaluation of Illness', 'timeFrame': '4 weeks', 'description': 'Mean difference in change in survey responses for measures of quality of life as assessed by the London Evaluation of Illness Tool.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient-Reported Outcomes', 'Post-dialysis Fatigue', 'Dialysis Recovery Time'], 'conditions': ['ESRD', 'Fatigue', 'Hemodialysis-Induced Symptom']}, 'descriptionModule': {'briefSummary': "A majority of patients with end-stage renal disease (ESRD) on in-center hemodialysis (HD) require several hours to recover from fatigue after an HD session. Evidence for practical interventions to improve this recovery time from conventional in-center HD is lacking. This study investigates the effects of reducing HD blood flow rates on patients' self-reported post-dialysis fatigue.", 'detailedDescription': "Post-dialysis fatigue reduces patients' quality of life and is also associated with cardiovascular events and mortality. Dialysis recovery time (DRT) is a measure of post-dialysis fatigue. Internationally, it has been found that more than a quarter of maintenance HD patients report \\>6 hours of DRT. The interventions showing the most improvement in DRT involve increases in treatment time, suggesting that post-dialysis fatigue may be in part related to the rate of solute clearance. Solute clearance rate is just one part of extending dialysis time, and its effect on DRT in patients undergoing typical-length dialysis sessions is not known. There is scant evidence to guide blood flow rate prescriptions aside from meeting clearance targets. Blood flow rate reductions are easily-implementable interventions that would slow solute clearance rates and may have an effect on post-dialysis fatigue."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of end-stage renal disease undergoing hemodialysis in the San Francisco Bay Area at approved Satellite Healthcare dialysis centers.\n* Dialysis recovery time of 6 or more hours.\n* Not hospitalized in the 7 days prior to study\n\nExclusion Criteria:\n\n* Currently or possibly pregnant, currently trying to become pregnant\n* Inability to provide informed consent\n* Inability to provide responses to survey questions\n* Planned move away from the current hemodialysis center within the study period\n* Undergoing nocturnal hemodialysis, planned changed to nocturnal or peritoneal dialysis, planned kidney transplant within the study period, or other major planned change in hemodialysis prescription\n* Primary nephrologist objection to enrollment'}, 'identificationModule': {'nctId': 'NCT03943212', 'briefTitle': 'The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Satellite Healthcare'}, 'officialTitle': 'The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis - A Prospective, Parallel-Group, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SR064RT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood Flow Rate Reduction', 'description': 'Participants will have their hemodialysis blood flow rate reduced on their regular schedule.', 'interventionNames': ['Other: Blood Flow Rate Reduction']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Participants will continue to receive regularly-scheduled hemodialysis without any changes to the prescription.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Blood Flow Rate Reduction', 'type': 'OTHER', 'description': 'Hemodialysis blood flow rate will be reduced by 100 mL/min, or to a minimum of 300 mL/min, whichever is higher. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.', 'armGroupLabels': ['Blood Flow Rate Reduction']}, {'name': 'Control', 'type': 'OTHER', 'description': 'No changes will be made to the dialysis prescription. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95010', 'city': 'Capitola', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Capitola', 'geoPoint': {'lat': 36.97523, 'lon': -121.95329}}, {'zip': '94014', 'city': 'Daly City', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Daly City', 'geoPoint': {'lat': 37.70577, 'lon': -122.46192}}, {'zip': '95020', 'city': 'Gilroy', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Gilroy', 'geoPoint': {'lat': 37.00578, 'lon': -121.56828}}, {'zip': '94025', 'city': 'Menlo Park', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Menlo Park', 'geoPoint': {'lat': 37.45383, 'lon': -122.18219}}, {'zip': '95035', 'city': 'Milpitas', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Milpitas', 'geoPoint': {'lat': 37.42827, 'lon': -121.90662}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Mountain View', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '95116', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis East San Jose', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95119', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Santa Teresa', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95121', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Silver Creek', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95123', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis South San Jose', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95127', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis White Road', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Bascom', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95129', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Stevens Creek', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94577', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis West San Leandro', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '94403', 'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis San Mateo', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'zip': '94080', 'city': 'South San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis South San Francisco', 'geoPoint': {'lat': 37.65466, 'lon': -122.40775}}, {'zip': '94086', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Sunnyvale', 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}, {'zip': '95076', 'city': 'Watsonville', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Watsonville', 'geoPoint': {'lat': 36.91023, 'lon': -121.75689}}], 'overallOfficials': [{'name': 'Brigitte Schiller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief Medical Officer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Satellite Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Medical Officer', 'investigatorFullName': 'Brigitte Schiller-Moran, MD', 'investigatorAffiliation': 'Satellite Healthcare'}}}}