Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT01828658
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
2013-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Bioimpedance vs Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-13', 'studyFirstSubmitDate': '2013-04-07', 'studyFirstSubmitQcDate': '2013-04-08', 'lastUpdatePostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '2,5 years follow-up', 'description': 'We assessed all-cause mortality in the two arms of the study at the end of intervention period.'}], 'secondaryOutcomes': [{'measure': 'Arterial stiffness', 'timeFrame': '3,5 years', 'description': 'Arterial stiffness was evaluated by applanation tonometry, measuring pulse wave velocity, and was done with a SphygmoCor® device (AtCor Medical, Westmead, Sydney, Australia).\n\nMeasurements were performed in both arms at baseline, end of intervention (2,5 years) and at the end of the study (3,5 years).'}, {'measure': 'Blood pressure values', 'timeFrame': '2,5 years', 'description': 'In both arms, blood pressure was measured predialysis every 3 months and noted as a mean of the previous 3 predialysis BP values.'}, {'measure': 'Overhydration', 'timeFrame': '2,5 years', 'description': 'Overhydration was evaluated in both arms of the study using the Body Composition Monitor (BCM device), every 3 months. Overhydration was quantified as Relative fluid overload (RFO = overhydration/ total body water - as measured by the BCM.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hemodialysis', 'fluid management', 'bioimpedance', 'mortality', 'arterial stiffness'], 'conditions': ['Haemodialyzed Patients', 'Volume Status']}, 'referencesModule': {'references': [{'pmid': '24583055', 'type': 'DERIVED', 'citation': 'Onofriescu M, Hogas S, Voroneanu L, Apetrii M, Nistor I, Kanbay M, Covic AC. Bioimpedance-guided fluid management in maintenance hemodialysis: a pilot randomized controlled trial. Am J Kidney Dis. 2014 Jul;64(1):111-8. doi: 10.1053/j.ajkd.2014.01.420. Epub 2014 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'The investigators developed a prospective, randomized, controlled trial to compare strict volume control using bioimpedance (using the BCM - Body Composition Monitor device) versus traditional clinical volume control in hemodialysis patients and the impact on mortality, hydration status, blood pressure values and arterial stiffness.', 'detailedDescription': 'The investigators developed a randomized controlled study to compare exclusively bioimpedance guided ultrafiltration in hemodialysis patients versus traditional methods for volume assessment.\n\nThe duration of the study was 3,5 years.\n\nDuring the first 2,5 years of the study all enrolled patients were randomized using a block randomization algorithm in two arms.\n\nIn the interventional arm the post-dialysis dry weight was prescribed exclusively using the BCM device (Body Composition Monitor - Fresenius Medical Care, Germany).\n\nIn the control arm dry weight assessment was done by traditional clinical methods.\n\nIn both arms,during the intervention period (2,5 years) BCM measurements were performed every 3 months before dialysis, but only in the interventional arm the values were disclosed to the medical personnel and used to guide the dry weight and ultrafiltration volumes.\n\nIn the control arm (clinical), both patients and caregivers were fully blinded from the BCM results.\n\nThe BCM device measures for each patient an ideal dry weight interval ( +/- 1.1 kg). In the interventional arm, the prescribed dry weights of the patients were strictly maintained in the ideal weight interval (+/- 1.1 kg) proposed by the BCM device.\n\nPrimary outcome was all cause-mortality compared in the strict bioimpedance arm versus the clinical (control) arm and was assessed at 2,5 years.\n\nSecondary end-points, assessed during the randomization period (2,5 years), were to compare blood pressure (determined pre dialysis), arterial stiffness and relative fluid overload (RFO = overhydration/ total body water), as measured by the BCM device.\n\nDuring the last year of the study, all patients were left free of any intervention, and only arterial stiffness was assessed a third time at 3,5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18-year\n* on chronic hemodialysis for more than 3 months\n\nExclusion Criteria:\n\n\\- life expectancy of less than 1 year\n\nPresence of a condition that may interfere with the determination of dry weight using the Body Composition Monitor (R):\n\n* severe ascites (decompensated liver failure)\n* limb amputations\n* cardiac stent, pacemaker or defibrillator\n* hip prosthetic\n* pregnancy\n* mental deficiency (impossibility to give consent)'}, 'identificationModule': {'nctId': 'NCT01828658', 'acronym': 'BIAHD', 'briefTitle': 'Randomized Bioimpedance vs Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Grigore T. Popa University of Medicine and Pharmacy'}, 'officialTitle': 'Bioimpedance Versus Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients: a Randomized Trial', 'orgStudyIdInfo': {'id': 'BCM0913'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Clinical (control)', 'description': 'In the clinical arm, dry weight and ultrafiltration prescription were done exclusively using traditional clinical methods of volume assessment.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bioimpedance arm', 'description': 'Strict bioimpedance guided dry weight prescription arm. All patients dry weights were permanently maintained in the dry weight interval recommended by the BCM device (+/- 1,1 kg); BCM measurements were performed every 3 months.', 'interventionNames': ['Other: Strict bioimpedance guided dry weight prescription']}], 'interventions': [{'name': 'Strict bioimpedance guided dry weight prescription', 'type': 'OTHER', 'description': 'Post dialysis patient dry weight was exclusively prescribed using the ideal weight measured by the BCM device (+/- 1.1 Kg).', 'armGroupLabels': ['Bioimpedance arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Adrian Covic, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Medicine and Pharmacy Iasi, "Dr. C.I.Parhon" University Hospital Iasi, Nephrology Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grigore T. Popa University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr.', 'investigatorFullName': 'Professor Adrian Covic', 'investigatorAffiliation': 'Grigore T. Popa University of Medicine and Pharmacy'}}}}