Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-03-06 @ 6:03 PM
Study NCT ID:
NCT00878033
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2009-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum Samples will be frozen for later Cytokine Sampling.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2009-04-07', 'studyFirstSubmitQcDate': '2009-04-07', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Autonomic Dysfunction', 'Chronic Renal Failure']}, 'referencesModule': {'references': [{'pmid': '27809785', 'type': 'DERIVED', 'citation': 'Seibert E, Zohles K, Ulrich C, Kluttig A, Nuding S, Kors JA, Swenne CA, Werdan K, Fiedler R, Girndt M. Association between autonomic nervous dysfunction and cellular inflammation in end-stage renal disease. BMC Cardiovasc Disord. 2016 Nov 3;16(1):210. doi: 10.1186/s12872-016-0385-1.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the relationship between autonomic dysfunction and chronic inflammation in hemodialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic and Non-diabetic Dialysis Patients. Healthy Controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Kidney Disease Stadium KDIGO 5D for at leat 3 months on Dialysis\n* Age \\>18 years\n* Sinus action in EKG\n* Patient capable for informed consent\n* Written and signed informed consent\n\nExclusion Criteria:\n\n* Clinical overt signs of infections of any kind\n* Active malign disease\n* CRP levels above 50 mg/L\n* Cardiac Pace Maker\n* Atrial Fibrillation\n* Refusal of informed consent\n* Cardiac Transplantation\n* Immunosuppressive medication'}, 'identificationModule': {'nctId': 'NCT00878033', 'briefTitle': 'Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Martin-Luther-Universität Halle-Wittenberg'}, 'officialTitle': 'Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'UKH-KIMII-001-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Diabetic Dialysis Patients'}, {'label': '2', 'description': 'Non-Diabetic Dialysis Patients'}, {'label': '3', 'description': 'Healthy Controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06120', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Martin-Luther-Universität Halle-Wittenberg, Dept. of Internal Medicine II', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}], 'overallOfficials': [{'name': 'Matthias Girndt, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Halle, Dept. of Internal Medicine II'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. habil. Matthias Girndt, Director, Martin-Luther-Universität Halle-Wittenberg, Dept. of Internal Medicine II', 'investigatorFullName': 'Matthias Girndt', 'investigatorAffiliation': 'Martin-Luther-Universität Halle-Wittenberg'}}}}