Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-01-06 @ 5:01 PM
Study NCT ID:
NCT01749761
Status:
COMPLETED
Last Update Posted:
2014-06-17
First Post:
2012-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006435', 'term': 'Renal Dialysis'}, {'id': 'D001676', 'term': 'Biofeedback, Psychology'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-14', 'studyFirstSubmitDate': '2012-12-12', 'studyFirstSubmitQcDate': '2012-12-13', 'lastUpdatePostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Oxygenation saturation', 'timeFrame': '8 weeks', 'description': 'Reduction in the minimum 02 saturation achieved'}], 'primaryOutcomes': [{'measure': 'intradialytic hypotension episodes', 'timeFrame': 'By the end of the 8 week intervention period', 'description': 'A 30% reduction in the frequency of HD sessions complicated by IDH. IDH is defined as a reduction in systolic BP of \\> = 20 mmHg if the pre-dialysis BP is \\>= 100 mmHg and with patient symptoms or nursing intervention. IDH is defined as a reduction in systolic BP of \\>=10 mmHg if predialysis BP \\< = 90mm Hg and with patient symptoms or nursing interventions'}], 'secondaryOutcomes': [{'measure': 'urea clearance', 'timeFrame': '8 weeks', 'description': 'Change in urea clearance'}, {'measure': 'Brain natriuretic peptide', 'timeFrame': '8 weeks', 'description': 'change in BNP'}, {'measure': 'intradialytic hypotension (blood pressure criteria alone)', 'timeFrame': '8 weeks', 'description': 'Reduction in the number of IDH episodes based on BP criteria alone'}, {'measure': 'Intradialytic symptoms', 'timeFrame': '8 weeks', 'description': 'Reduction in the number of intradialytic symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IDH, intradialytic hypotension,', 'hypotension on hemodialysis,', 'hemodialysis,', 'Blood pressure guided biofeedback'], 'conditions': ['Hypotension']}, 'descriptionModule': {'briefSummary': "It is very common for hemodialysis patients to have problems with low blood pressure while on hemodialysis. Low blood pressure on dialysis is not a good thing and it is associated with an increased risk of death and hospitalizations. It might be possible to minimize or even prevent these low blood pressure episodes with a software that can be added to the dialysis machine which detects the patient's changes in blood pressure and automatically slows down how much fluid is being removed from the person.\n\nThe investigators hypothesize that a blood pressure guided biofeedback system (called BioLogics RR) will result in a 30% reduction in the number of hypotensive episodes on hemodialysis.", 'detailedDescription': 'This is a randomized cross over trial in which 30 chronic hemodialysis patients with a history of intradialytic hypotension, IDH will be randomized to receive either standard hemodialysis or hemodialysis with blood pressure guided biofeedback (BioLogics RR Comfort, B braun). After the initial period of 8 weeks patients will cross over to the other group for the final 8 weeks of the study.\n\nThe primary outcome is the reduction in the number of IDH episodes associated with patient symptoms or nursing symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic hemodialysis patients\n* history of 3 of the last 12 runs with documented hypotension with symptoms or nursing interventions\n\nExclusion Criteria:\n\n* \\<19 years\n* hemodiafiltration\n* expected switch in modality within next 6 months'}, 'identificationModule': {'nctId': 'NCT01749761', 'acronym': 'BP-RIDH', 'briefTitle': 'Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotensive Episodes: A Randomized Cross Over Trial', 'orgStudyIdInfo': {'id': 'H12-02619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Hemodialysis without biofeedback', 'description': 'Patients will be randomized to receive hemodialysis without biofeedback for a period of 8 weeks.', 'interventionNames': ['Other: BioLogic RR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BioLogic RR biofeedback', 'description': 'Patients will receive 8 weeks of HD with BioLogic RR Blood pressure guided biofeedback.', 'interventionNames': ['Other: Hemodialysis without biofeedback']}], 'interventions': [{'name': 'BioLogic RR', 'type': 'OTHER', 'otherNames': ['BioLogics Comfort RR, B Braun software'], 'description': 'Patients will be randomized to BP guided biofeedback arm which will entail regular hemodialysis with a software program turned on to allow frequent assessment of blood pressure and automated adjustments of the ultrafiltration rate based on these blood pressure measurements. The duration of this arm is 8 weeks', 'armGroupLabels': ['Hemodialysis without biofeedback']}, {'name': 'Hemodialysis without biofeedback', 'type': 'OTHER', 'otherNames': ['Hemodialysis'], 'description': 'patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks', 'armGroupLabels': ['BioLogic RR biofeedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St.Paul's Hospital Hemodialysis Unit", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Jennifer M MacRae, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of British Columbia', 'class': 'OTHER'}, {'name': 'B. Braun Medical Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Dr Jennifer MacRae', 'investigatorAffiliation': 'University of Calgary'}}}}