Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT02962635
Status:
COMPLETED
Last Update Posted:
2021-08-10
First Post:
2016-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Biomarkers in Patients Undergoing Dialysis Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-09', 'studyFirstSubmitDate': '2016-11-02', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of sCD146 level with overhydration assessed by bioimpedance technology', 'timeFrame': '3 weeks to 3 months', 'description': 'For hemodialysis patients measurements will be concluded within 3 weeks, for peritoneal dialysis patients measures will be concluded within 3 months'}], 'secondaryOutcomes': [{'measure': 'Correlation of sCD146 level measured after dialysis and ultrafiltration rate', 'timeFrame': '3 weeks', 'description': 'for hemodialysis patients measurements will be concluded within 3 weeks'}, {'measure': 'Correlation of sCD146 level and clinical evaluation of volume status', 'timeFrame': '3 weeks to 3 months', 'description': 'For hemodialysis patients measurements will be concluded within 3 weeks, for peritoneal dialysis patients measures will be concluded within 3 months'}, {'measure': 'Correlation of sCD146 level and level of NT-proBNP', 'timeFrame': '3 weeks to 3 months', 'description': 'For hemodialysis patients measurements will be concluded within 3 weeks, for peritoneal dialysis patients measures will be concluded within 3 months'}, {'measure': 'Correlation of sCD146 level and mortality as assessed prospectively in 6 months follow-up', 'timeFrame': '6 months'}, {'measure': 'Correlation of sCD146 level and hospitalizations as assessed prospectively in 6 months follow-up', 'timeFrame': '6 months'}, {'measure': 'Correlation of sCD146 level and cardiovascular complications as assessed prospectively in 6 months follow-up', 'timeFrame': '6 months'}, {'measure': 'Correlation of sCD146 level and shunt complications as assessed prospectively in 6 months follow-up', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Volemia in Dialysis Patients']}, 'descriptionModule': {'briefSummary': 'A precise volume status assessment is critical to improve outcome of patients on dialysis. Yet, accurate assessment of fluid status remains a challenge. Currently, this is performed by clinical evaluation and regular weight measurements before and after dialysis, which is not always accurate. Moreover, bioimpedance technology is used in some centers for quantitative assessment of total body water. This approach has been validated for the assessment of volume status in dialysis patients, but requires the acquisition of specific tools and is time consuming. So far, no biomarker has been validated to quantify volume status in dialysis patients. Application of biomarkers might contribute to a better dialysis prescription and therefore to outcome improvement in dialysis. The investigators aim to investigate the role of a novel biomarkers (sCD146) to assess volume status in dialysis patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with end stage renal failure on hemodialysis and peritoneal dialysis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Patient on dialysis since \\> 1 month\n* Voluntarily signed informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women and women who plan to get pregnant during study\n* Incapability of following the study protocol\n* Acute illness\n* Hospitalizations in the last week before inclusion\n* Cardiac pacemakers or defibrillators\n* Limb amputation or other factors precluding a reliable bioimpedance measurement (unreliable bioimpedance measurement)'}, 'identificationModule': {'nctId': 'NCT02962635', 'acronym': 'DRYWEIGHT', 'briefTitle': 'Role of Biomarkers in Patients Undergoing Dialysis Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'A Pilot stuDy to Investigate the Role of Biomarkers and Bioimpedance technologY to Assess VolumE Status In Patients underGoing Hemodialysis Treatment', 'orgStudyIdInfo': {'id': 'DRYWEIGHT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemodialysis patients', 'description': 'A total of 30 patients\n\n\\- measuring volume status by bioelectrical impedance measurement as well as clinical evaluation and comparing with the novel biomarker', 'interventionNames': ['Device: bioelectrical impedance measurement and biomarker measurement']}, {'label': 'Peritoneal dialysis patients', 'description': 'A total of 15 patients\n\n\\- measuring volume status by bioelectrical impedance measurement as well as clinical evaluation and comparing with the novel biomarker', 'interventionNames': ['Device: bioelectrical impedance measurement and biomarker measurement']}], 'interventions': [{'name': 'bioelectrical impedance measurement and biomarker measurement', 'type': 'DEVICE', 'description': 'Measuring volume status with bioelectrical impedance measurement and comparing with biomarker level', 'armGroupLabels': ['Hemodialysis patients', 'Peritoneal dialysis patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8901', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Stephan Segerer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zürich, Zürich, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}