Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT03764358
Status:
UNKNOWN
Last Update Posted:
2018-12-05
First Post:
2018-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AUSTrian Randomized Interventional Study on Dialysis Accesses
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001166', 'term': 'Arteriovenous Shunt, Surgical'}], 'ancestors': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2022-10-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-03', 'studyFirstSubmitDate': '2018-12-03', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite primary end-point of any access related complication', 'timeFrame': 'From placement of vascular access through study completion, an average of 3 years.', 'description': 'Loss of access, catheter related bloodstream infection/shunt infection and/or thrombosis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['End Stage Renal Disease', 'Catheter Infection', 'Shunt Malfunction']}, 'descriptionModule': {'briefSummary': 'Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a "fistula first" approach for every patient, whenever possible. Thus, every patient, regardless of age, clinical state and co-morbidities an arteriovenous fistula should be preferred over a tunneled cuffed catheter (TCC). These recommendations are based on retrospective and register studies. There have been no prospective studies in this subject so far. In addition, most of the collected data refers to patients of all ages, regardless of their comorbidities and general clinical state. In this study, we address differences between two dialysis vascular access types in elderly or frail patients. We will compare TCCs with arteriovenous fistulas in the selected population consisting of elderly patients over 60 years of age or those with a Charlson Comorbidity Index \\>6 independent of age. In our hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the examined end-points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 60 and higher\n* CCI Score \\>6 when under 60 years\n* Patients with CKD G5 A1-3 with indication for hemodialysis\n* Stable clinical condition\n* Eligibility for both arteriovenous fistula on the upper extremitiesandTCC\n* Availability for follow-up.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Uncontrolled infection at screening and/or CRP \\>5 mg/dl (normal \\<0.5 mg/dl) at screening.\n* Poor general condition of health or malignancy not in remission at screening\n* Major surgery within 12 weeks before screening.\n* Pre-existent vascular access.\n* Patient not eligible for any one of the vascular access options.'}, 'identificationModule': {'nctId': 'NCT03764358', 'acronym': 'AUSTRIA', 'briefTitle': 'AUSTrian Randomized Interventional Study on Dialysis Accesses', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients', 'orgStudyIdInfo': {'id': 'AUSTRIA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arteriovenous fistula', 'interventionNames': ['Device: Arteriovenous Fistula']}, {'type': 'EXPERIMENTAL', 'label': 'Tunneled Cuffed Catheter', 'interventionNames': ['Device: Tunneled Cuffed Catheter']}], 'interventions': [{'name': 'Arteriovenous Fistula', 'type': 'DEVICE', 'description': 'Surgical implantation of an arteriovenous fistula for hemodialysis', 'armGroupLabels': ['Arteriovenous fistula']}, {'name': 'Tunneled Cuffed Catheter', 'type': 'DEVICE', 'description': 'Placement of a tunneled cuffed catheter in surgical theatre', 'armGroupLabels': ['Tunneled Cuffed Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'contacts': [{'name': 'Benjamin Schairer, MD', 'role': 'CONTACT', 'email': 'benjamin.schairer@meduniwien.ac.at', 'phone': '0043 40400', 'phoneExt': '43890'}], 'facility': 'Department of Medicine III, Devision of Nephrology and Dialysis, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Benjamin Schairer, MD', 'role': 'CONTACT', 'email': 'benjamin.schairer@meduniwien.ac.at', 'phone': '0043 40400 43890'}], 'overallOfficials': [{'name': 'Guerkan Sengoelge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna, Department of Medicine III, Devision of Nephrology and Dialysis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Priv.-Doz. Dr.', 'investigatorFullName': 'Guerkan SENGOELGE', 'investigatorAffiliation': 'Medical University of Vienna'}}}}