Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01103167
Status:
UNKNOWN
Last Update Posted:
2010-04-14
First Post:
2010-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Body Composition Monitor in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-11-04', 'releaseDate': '2011-10-01'}], 'estimatedResultsFirstSubmitDate': '2011-10-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-13', 'studyFirstSubmitDate': '2010-04-09', 'studyFirstSubmitQcDate': '2010-04-13', 'lastUpdatePostDateStruct': {'date': '2010-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': 'up to 16 weeks', 'description': 'Systolic blood pressure, number of anti-hypertensive agents hypotensive episode'}], 'secondaryOutcomes': [{'measure': 'biomarkers', 'timeFrame': 'up to 16 weeks', 'description': 'C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['body composition', 'blood pressure', 'hemodialysis'], 'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Control of volume status is a pivotal issue in haemodialysis therapy. Objective and practical management for maintaining normovolemia is needed.\n\nThe investigators hypothesized that intervention of volume status with the body composition monitor (BCM) may improved hemodynamic parameters and biomarkers in hemodialysis patients.', 'detailedDescription': "The investigators will assess BCM in enrolled hemodialysis patients by 4 weeks for 16 weeks During the former 8-week intervention period, The investigators will adjust patients' volume status according to the results of BCM.\n\nDuring the latter 8-week observational period, The investigators will evaluate the changes of patients' hemodynamic parameters and biomarkers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6-month or more stable hemodialysis patients\n* 18 years or more\n* less than 5% of changes of dry weight for last 3 months\n\nExclusion Criteria:\n\n* pregnancy\n* active malignancy\n* cardiac pacemaker or defibrillator\n* history of extremity amputation\n* active infectious disease within 3 months\n* admission history for complication related to hemodialysis within 3 months'}, 'identificationModule': {'nctId': 'NCT01103167', 'briefTitle': 'Body Composition Monitor in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'The Association Between Body Composition and Biomarkers in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'korea_bcm_hd'}}, 'armsInterventionsModule': {'interventions': [{'name': 'control of ultrafiltration', 'type': 'BEHAVIORAL', 'description': 'During the interventional period, dry weight of patients will be adjusted according to the results of body composition.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '405-760', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sejoong Kim, MD, PhD', 'role': 'CONTACT', 'email': 'imsejoong@hanmail.net', 'phone': '82-32-460-8305'}, {'name': 'Kwon Wook Joo, MD, PhD', 'role': 'CONTACT', 'email': 'junephro@paran.com', 'phone': '82-2-2072-1964'}, {'name': 'Kwon Wook Joo, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ho Jun Chin, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sejoong Kim', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Sejoong Kim, MD, PhD', 'role': 'CONTACT', 'email': 'imsejoong@hanmail.net', 'phone': '82-32-460-8305'}, {'name': 'Kwon Wook Joo, MD, PhD', 'role': 'CONTACT', 'email': 'junephro@paran.com', 'phone': '82-2-2072-1964'}], 'overallOfficials': [{'name': 'Sejoong Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University Gil Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Gachon University Gil Medical Center IRB', 'oldOrganization': 'Gachon University Gil Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-10-01', 'type': 'RELEASE'}, {'date': '2011-11-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sejoong Kim, Principal Investigator, Gachon University Gil Medical Center'}}}}