Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-29 @ 11:38 AM
Study NCT ID:
NCT00397306
Status:
COMPLETED
Last Update Posted:
2009-04-08
First Post:
2006-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-07', 'studyFirstSubmitDate': '2006-11-07', 'studyFirstSubmitQcDate': '2006-11-07', 'lastUpdatePostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioimpedance Dry weight'}], 'secondaryOutcomes': [{'measure': 'Resistance'}, {'measure': 'Resistivity'}, {'measure': 'Blood pressure'}, {'measure': 'LV Diameter'}, {'measure': 'Shortening Fraction'}, {'measure': 'Wall thickness LA, LV'}, {'measure': 'Quality of Life'}, {'measure': 'EPO-Dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Insufficiency, Chronic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the evaluation of a bioimpedance method for determination of dry weight in dialysis patients. Additionally normal tissue hydration in non-Dialysis patients is investigated in healthy subjects and patients with chronic kidney disease in stages K/DIGO I-IV'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically stable on dialysis within the last three months\n* signed written informed consent\n\nExclusion Criteria:\n\n* acute myocardial infarction or stroke within the last six months\n* heart failure stage NYHA IV\n* concommitant participation in other interventional trials\n* psychiatric conditions that prevent subject from following the study procedures / protocol\n* pregnancy or lactation\n* limb amputation\n* cardiac pacemaker\n* joint implants\n* implantable pumps and other metallic implants\n\nFor healthy subjects and CKD patients in stages K/DIGO I-IV the above mentioned criteria other than the first mentioned are applicable respectively.'}, 'identificationModule': {'nctId': 'NCT00397306', 'briefTitle': 'Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Saarland'}, 'officialTitle': 'Study for the Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients', 'orgStudyIdInfo': {'id': '95/06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bioimpedance Analysis', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'country': 'Germany', 'facility': 'University Hospital of Saarland, Dept. of Internal Medicine IV, Div. of Nephrology and Hypertension', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}], 'overallOfficials': [{'name': 'Eric Seibert, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Saarland, Department of Internal Medicine IV, Division of Nephrology and Hypertension'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Saarland', 'class': 'OTHER'}}}}