Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-31 @ 5:22 PM
Study NCT ID:
NCT01492634
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2011-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Fluid Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014869', 'term': 'Water Intoxication'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-27', 'studyFirstSubmitDate': '2011-12-07', 'studyFirstSubmitQcDate': '2011-12-13', 'lastUpdatePostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intra-individual difference in TAFO between study start and study end', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Comparison between start and end of treatment will be performed for Pre-dialytic overhydration (OH)', 'timeFrame': '3 months'}, {'measure': 'Comparison between start and end of treatment will be performed for number of patients in target range (TAFO from -0.2 L to 1.3 L)', 'timeFrame': '3 months'}, {'measure': 'SF 36 total score and sub-scores as calculated according to official guidelines,', 'timeFrame': '3 months'}, {'measure': 'BNP', 'timeFrame': '3 months'}, {'measure': 'Blood pressure', 'timeFrame': '3 months'}, {'measure': 'laboratory parameters (sodium, calcium, potassium, chloride, haematocrit, haemoglobin, albumin, total protein, urea, creatinine, mean corpuscular volume, C-reactive protein, transferrin saturation, ferritin).', 'timeFrame': '3 months'}, {'measure': 'Change from Baseline in Medication at 12 weeks (erythropoetin, iron, blood pressure medication)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in intra-dialytic events (hypotension, cramps)', 'timeFrame': '3 months'}, {'measure': 'Change from baseline in Residual Renal Function', 'timeFrame': '3 months', 'description': 'Baseline Residual renal function, measured as Kt/V residual, wil be compared with the Residual renal function at the end of 12 weeks.'}, {'measure': 'Hospitalisation', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioimpedance', 'overhydration', 'dry weight'], 'conditions': ['Hypotension During Dialysis']}, 'referencesModule': {'references': [{'pmid': '23949235', 'type': 'RESULT', 'citation': 'Moissl U, Arias-Guillen M, Wabel P, Fontsere N, Carrera M, Campistol JM, Maduell F. Bioimpedance-guided fluid management in hemodialysis patients. Clin J Am Soc Nephrol. 2013 Sep;8(9):1575-82. doi: 10.2215/CJN.12411212. Epub 2013 Aug 15.'}]}, 'descriptionModule': {'briefSummary': 'Title of study: Optimizing Fluid Status\n\nStudy code: HD-IIT-01-E\n\nStudy design: Prospective open design in study centre at two locations\n\nApplied medical device: Body Composition Monitor (BCM) for determination of fluid overload and dry weight\n\nAim of the study: To improve the fluid status in chronic HD patients (measured as OH (overhydration) or TAFO (time averaged fluid overload)) based on BCM measurements. Up to now, the BCM was occasionally applied in both locations of the study centre.\n\nStudy hypothesis: Regular measurement of fluid status (assessed by BCM) and display of dry weight (post-weight plan)will have significant consequences, namely a decrease of the:\n\n* time averaged fluid overload (TAFO),\n* proportion of patients with severe overhydration OH \\> 2.5 L,or OH/ECW \\> 15 %)\n* proportion of dehydrated patients (OH \\< -1.0 L, or OH \\< -7 %),\n* mean overhydration,\n* variance of overhydration,\n* time outside the reference range (-1.0L \\< OH \\< 2.5L).\n\nDevices used in this study: Dialysis machine 5008 equipped with Blood Pressure Monitor BPM, Blood Volume Monitor BVM, Blood Temperature Monitor BTM, and Online Clearance Monitor OCM ; Body Composition Monitor BCM ; Data management software / database system NephroLink Disposables used in this study: BVM blood lines and BCM electrodes\n\nPatients: 60 patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic renal failure stage V\n* Treatment thrice weekly with HD or on-line HDF for at least 6 months prior to inclusion\n* Ability to understand the nature and requirements of the study\n* Age: at least 18 years\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Interventional clinical study during the preceding 30 days or previous participation in the same study\n* Acute or chronic infection (HIV, Hepatitis B or C, ...)\n* Severe disease (malignant tumour, tuberculosis ...)\n* Usually single needle HD\n* Problems with shunt or high recirculation,\n* Severe intra-dialytic blood pressure instability in the last month\n* Instable angina pectoris\n* Major amputation at arm or leg, or a pacemaker.'}, 'identificationModule': {'nctId': 'NCT01492634', 'briefTitle': 'Optimizing Fluid Status', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Clinical Investigation Plan Optimizing Fluid Status', 'orgStudyIdInfo': {'id': 'HD-IIT-01-E'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Prescription of post-dialytic weight based on BCM device', 'type': 'OTHER', 'otherNames': ['BCM or Body Composition Monitor Fresenius Medical Care'], 'description': 'Prescription of post-dialytic weight target: On a weekly base, the patients are pre-dialytically measured by BCM (body composition monitor).\n\nThe time average fluid overload (TAFO) determines the target range. TAFO is defined as the mean value of pre- and post-dialytic overhydration (TAFO = (OHpre+OHpost)/2). The target range is set asymmetrically around a TAFO of 0.8, from -1.0 L to +0.5, i.e. the TAFO target range will be from -0.2 L to 1.3 L.\n\nPrescription steps will be calculated weekly for all study patients. TAFO \\< -0.2 L: Increase post-dialytic weight by Cw x 0.5 kg/week, TAFO between -0.2 to 1.3 L: No action, TAFO between 1.3 to 2.8 L Decrease post-dialytic weight by Cw x 0.5 kg/week, TAFO \\> 2.8 L: Decrease post-dialytic weight by Cw x 1.0 kg/week.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Dialysis Units, Hospital Clínic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Francisco Maduell', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fresenius Medical Care Europe', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator; Head of Dialysis Section', 'investigatorFullName': 'Francisco Maduell', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}