Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-04-08 @ 5:26 AM
Study NCT ID:
NCT02325856
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2014-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jamespslim@gmail.com', 'phone': '886-4-26581919', 'title': 'Lim Paik-Seong', 'organization': "Department of Nephrology, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Study Group', 'description': 'Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)\n\nBioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.', 'otherNumAtRisk': 128, 'otherNumAffected': 0, 'seriousNumAtRisk': 128, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Dry weight determined by clinical symptoms', 'otherNumAtRisk': 123, 'otherNumAffected': 0, 'seriousNumAtRisk': 123, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'All-cause Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)\n\nBioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Dry weight determined by clinical symptoms'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '0.61'}, {'value': '0.54', 'groupId': 'OG001', 'lowerLimit': '0.46', 'upperLimit': '0.63'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'hospitalizations per patient-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications During DW Adjustment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}, {'units': 'months when dry weight adjustment happen', 'counts': [{'value': '816', 'groupId': 'OG000'}, {'value': '735', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)\n\nBioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Dry weight determined by clinical symptoms'}], 'classes': [{'categories': [{'measurements': [{'value': '11.76', 'groupId': 'OG000'}, {'value': '30.88', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'we wanted to compared whether the dialysis-related complications are different when DW (dry weight) is adjusted, no matter according to BCM (body composition monitor) results or clinical judgement, in both groups. The result is expressed as the percentage of months in which complications happened when DW adjustment presented (using total months which DW adjustments are present as denominator).', 'unitOfMeasure': '% of months in which compli', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'months when dry weight adjustment happen', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Group', 'description': 'Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)\n\nBioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Dry weight determined by clinical symptoms'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '27'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Group', 'description': 'Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)\n\nBioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Dry weight determined by clinical symptoms'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '62.4', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2014-12-22', 'resultsFirstSubmitDate': '2015-06-24', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-21', 'studyFirstPostDateStruct': {'date': '2014-12-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause Hospitalization', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Complications During DW Adjustment', 'timeFrame': '1 year', 'description': 'we wanted to compared whether the dialysis-related complications are different when DW (dry weight) is adjusted, no matter according to BCM (body composition monitor) results or clinical judgement, in both groups. The result is expressed as the percentage of months in which complications happened when DW adjustment presented (using total months which DW adjustments are present as denominator).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Body Composition Monitor'], 'conditions': ['Fluid Overload']}, 'descriptionModule': {'briefSummary': 'A reasonable and simple algorithm was used to guide the dry weight determination with Body Composition Monitor with the principle of Bioimpedance Spectroscopy (BCM-BIS) and analyze the feasibility of this algorithm and evaluate the influence of BCM-BIS-guided fluid management on the incidence of dialysis morbidities and clinical outcomes in maintenance hemodialysis (MHD) patients.', 'detailedDescription': "298 MHD patients in 6 hemodialysis centers in Taiwan were enrolled in this randomized controlled study. All the participants were randomized into study group ( dry weight (DW) determined by BCM-BIS) and control group ( dry weight determined by clinical symptoms) with stratification by diabetes mellitus and centers. Body composition monitor based on bioimpedance spectroscopy (BCM-BIS) was performed monthly and concomitant biochemical data and clinical outcomes were collected. Intra-dialysis complications were recorded in every dialysis session. Primary outcome was all-cause hospitalization. Secondary outcomes included 1) complications during DW adjustment 2) intra-dialysis morbidities 3) hypertension 4) mortality 5) acute fluid overload (AFO) or cardiovascular (CV)-related events. The clinical feasibility of the BCM-BIS algorithm was also inspected. Statistical methods: a software (SAS) 9.3 was used for statistical analysis in this study. R 3.0 was used for graphic presentation of parts of the results. Relative risk, incidence rate ratio and Fisher's exact test were used to compare the discrete outcomes in both groups. Survival analysis was used for time-related events. Repeated-measured and longitudinal data were analyzed with the generalized linear mixed model (GLMM) through the procedure for continuous variables (PROC MIXED) and for discrete variables (PROC GLIMMIX) in SAS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMHD patients with age ≥ 18 and dialysis vintage ≥ 3 months\n\nExclusion Criteria:\n\n1. coronary stents or pacemaker implantation\n2. metallic devices in body, such as artificial joints or pins\n3. contralateral or bilateral amputations\n4. pregnancy'}, 'identificationModule': {'nctId': 'NCT02325856', 'briefTitle': 'Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'An Hsin QingShui Clinic'}, 'officialTitle': 'Effect of Post-dialysis Weight Evaluated With Bioimpedance Spectroscopy on Dialysis Morbidities and Clinical Outcomes in Hemodialysis Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ABISAD-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study group', 'description': 'Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)', 'interventionNames': ['Device: Bioimpedance Spectroscopy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Dry weight determined by clinical symptoms', 'interventionNames': ['Behavioral: Clinical judgement']}], 'interventions': [{'name': 'Bioimpedance Spectroscopy', 'type': 'DEVICE', 'description': 'Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.', 'armGroupLabels': ['Study group']}, {'name': 'Clinical judgement', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'An Hsin QingShui Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nephrocare AsiaPacific', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}