Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-29 @ 7:02 AM
Study NCT ID:
NCT00974857
Status:
COMPLETED
Last Update Posted:
2013-09-09
First Post:
2009-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects Of Volume Control Guided by Body Composition Monitor (BCM) on Blood Pressure and Cardiac Condition in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-06', 'studyFirstSubmitDate': '2009-09-09', 'studyFirstSubmitQcDate': '2009-09-09', 'lastUpdatePostDateStruct': {'date': '2013-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regression of left ventricular mass index (LVMI)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Changes in post-dialysis body weight', 'timeFrame': '1 year'}, {'measure': 'Achievement of normal blood pressure level without using anti-hypertensive medication', 'timeFrame': '1 year'}, {'measure': 'Decrease in left atrial volume', 'timeFrame': '1 year'}, {'measure': 'Hematocrit and related rHu-EPO doses', 'timeFrame': '1 year'}, {'measure': 'Serum levels of albumin and Hs-CRP', 'timeFrame': '1 year'}, {'measure': 'Plasma level of pro-BNP', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Left Ventricular Hypertrophy', 'Body Composition Monitor'], 'conditions': ['Left Ventricular Hypertrophy']}, 'descriptionModule': {'briefSummary': 'This prospective, randomized, controlled study aims to evaluate the usefulness of the new body composition monitor (BCM) device as a method to improve volume control in hemodialysis (HD) patients and compare the results with those obtained by conventional volume control modalities.', 'detailedDescription': 'The proposed prospective, randomized, controlled study intends to document the effect of volume control guided by BCM on blood pressure (determined both manually and 48-h ambulatory), need for anti-hypertensive medication, intra-dialytic complications, and left ventricular geometry and functions assessed by echocardiography. One hundred and seventy-six prevalent HD patients will be randomized into two arms: study group and control group.\n\nIn the study group, "overhydration (OH) in liters" will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH)at least once a month before a dialysis session in order to determine dry weight.\n\n1. If OH is positive value, we will try to reach dry weight by ultrafiltration without regard to the level of blood pressure.\n2. If OH is negative value , and:\n\n * Systolic blood pressure is \\< 100 mmHg with/or intradialytic hypotension episodes and/or clothing and/or erythrocytosis ( htc\\> 36 %); we will increase dry weight accordingly.\n * Systolic blood pressure is normal (100-150 mmHg) without intradialytic hypotension episodes and clothing and erythrocytosis; we will not change dry weight.\n * Systolic blood pressure normal (100-150 mmHg) with intradialytic hypotension episodes and/or clothing and/or erythrocytosis; we will increase dry weight.\n * Systolic blood pressure\\> 150 mmHg we will perform a captopril test (CT) If the CT is positive we will use ACE inhibitors / ARBs as anti hypertensive drugs and dry weight will be increased if intradialytic hypotension episodes and/or clothing and/or erythrocytosis ( htc\\> 36 %) are also present\n\nIf the CT is negative we will repeat the BCM measurement and if it gives same results we will perform ABPM for confirmation.\n\nWe will not need to reach the dry weight immediately. If severe BP drop precludes reaching DW in one session, an isolated ultrafiltration or additional dialysis session will be added.\n\nIn the control group, BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be.\n\nThe planned duration of the study is 12 months. All patients will be seen in every month during the study. Additional visits will be scheduled if any symptoms and intolerance are suspected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age older than 18-year,\n* Maintenance bicarbonate HD scheduled thrice weekly (12 hours/week),\n* Willingness to participate in the study with a written informed consent.\n\nExclusion Criteria:\n\n* Presence of a cardiac stent, pacemaker or defibrillator ,\n* Artificial joints, pin or amputation\n* Permanent or temporary catheters (may affect BCM measurement),\n* Being scheduled for living donor renal transplantation,\n* Presence of serious life-limiting co-morbid situations, like malignancy, uncontrollable infection, end-stage cardiac, pulmonary, or hepatic disease,\n* Pregnancy or lactating,\n* Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial,\n* Mental incompetence.'}, 'identificationModule': {'nctId': 'NCT00974857', 'briefTitle': 'Effects Of Volume Control Guided by Body Composition Monitor (BCM) on Blood Pressure and Cardiac Condition in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Effects Of Volume Control Guided By Bioimpedance Spectroscopy On Blood Pressure And Cardiac Condition In Hemodialysis Patients', 'orgStudyIdInfo': {'id': '09-4/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study group', 'description': 'Pre-dialytic overhydration(OH) will be estimated by Body Composition Monitor (BCM) at least once a month.\n\n1. If OH is positive, dry weight will be reached by ultrafiltration without regard to the level of blood pressure.\n2. If OH is negative and:\n\n * Systolic blood pressure(SBP)\\< 100 mmHg with/or intradialytic hypotension episodes(IDHE) and/or clothing and/or erythrocytosis(htc\\>36%);dry weight will be increased.\n * SBP normal(100-150 mmHg) w/o IDHE and clothing and erythrocytosis;dry weight will not be changed.\n * SBP normal(100-150 mmHg) with IDHE and/or clothing and/or erythrocytosis;dry weight will be increased.\n * SBP\\>150 mmHg captopril test(CT)will be done. If CT is positive, ACEI/ ARBs will be used and dry weight will be increased if IDHE and/or clothing and/or erythrocytosis(htc\\>36%) are present.\n\nIf CT is negative, BCM measurement will be repeated and if same,ABPM will be performed for confirmation.', 'interventionNames': ['Device: BCM']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be.', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'BCM', 'type': 'DEVICE', 'otherNames': ['Body Composition Monitor,Fresenius Medical Care,Deutschland'], 'description': 'Overhydration (OH) in liters will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH) in order to determine dry weight at least once a month before a dialysis session.', 'armGroupLabels': ['Study group']}, {'name': 'control group', 'type': 'OTHER', 'description': 'BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Bornova', 'state': 'İzmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University Division of Nephrology', 'geoPoint': {'lat': 38.47921, 'lon': 27.2399}}], 'overallOfficials': [{'name': 'Ercan Ok, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ege University Division of Nephrology'}, {'name': 'Gulay Asci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University Division of Nephrology'}, {'name': 'Ender Hur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University Division of Nephrology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fresenius Medical Care North America', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ercan OK', 'investigatorAffiliation': 'Ege University'}}}}