Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-29 @ 1:58 PM
Study NCT ID:
NCT06987032
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2025-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamics in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-03', 'size': 1497003, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-15T09:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'whole body fluid status', 'timeFrame': 'Baseline, every 3 months during 1 year', 'description': 'The primary objective is to associate the bioimpedance-determined fluid status \\[fluid overload versus non-fluid overload\\] with kidney function decline in patients with chronic kidney disease stage 3 (59-30ml/min), 4 (29-15ml/min) and 5 (\\< 15 ml/min).'}], 'secondaryOutcomes': [{'measure': 'identify the clinical factors associated with fluid overload during a longitudinal follow up', 'timeFrame': 'Baseline, every 3 months during 1 year', 'description': 'Secondary outcomes of interest are the central volume status (measured as ejection fraction in % by echocardiography and thoracic bioimpedance in Ohms in combination with photoplethysmography), the cardiac systolic and diastolic function (measured by echocardiography), cardiovascular events, hospitalizations, inflammatory- and nutrition status (by whole body bioimpedance measurements), and quality of life (by Short Form 36 questionnaire).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Failure']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the role of thoracic and whole body bioimpedance in the hemodynamic profile of patients with chronic kidney disease.\n\nThe main question it aims to answer is:\n\n\\- Is bioimpedance-determined fluid status associated with kidney function decline in patients with chronic kidney disease stage 3 - 5 (non dialysis).', 'detailedDescription': 'Participants will be measured during their regular visit to their treating nephrologist.\n\nDuring a follow up of one year, 3 or 4 visits will be scheduled.\n\n* Bioimpedance and blood pressure measurements will be achieved by non-invasive techniques.\n* Blood sampling will as much as possible coincide with regular blood samplings for clinical purposes.\n* All subjects will undergo echocardiography at baseline and after one year follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '206 patients with CKD stages 3-5 will be included from the outpatient clinic of Ziekenhuis Zuid-Oost Limburg in Genk (Belgium).\n\nA healthy control group for the cross-sectional part will be recruited through visitors and/or personnel of Ziekenhuis Oost-Limburg in Genk (Belgium).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prevalent non-dialysis patients with estimated glomerular filtration rate \\< 60 ml/min (for chronic kidney disease subjects)\n* Age \\> 18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Acute kidney injury\n* estimated glomerular filtration rate \\< 20ml/min directly post-nephrectomy\n* Clinical conditions affecting bioimpedance measurements: limb amputation, impaired skin integrity, brain stimulator, pacemaker with low threshold or unipolar pacemaker.\n* Clinical conditions affecting body composition: liver cirrhosis, active infectious disease or any acute cardiovascular event (defined as cerebrovascular event, myocard infarction, heart failure) during the 3 months before screening for inclusion\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06987032', 'acronym': 'HORUZ', 'briefTitle': 'Hemodynamics in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Ziekenhuis Oost-Limburg'}, 'officialTitle': 'Improving the Hemodynamic Profile Of Chronic Renal Patients by Use of Bioimpedance', 'orgStudyIdInfo': {'id': 'ctu2019039'}}, 'contactsLocationsModule': {'locations': [{'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Medicine and Life science', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Pieter Vandervoort, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hasselt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}