Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-05 @ 12:14 PM
Study NCT ID:
NCT02479295
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2015-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'straight versus coiled Tenckhoff catheters'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2015-06-19', 'studyFirstSubmitQcDate': '2015-06-23', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of catheter dysfunction that requires intervention', 'timeFrame': 'One year', 'description': 'Catheter dysfunction refers to drainage failure, as defined by the inability to drain peritoneal dialysate effluent reliably within 45 minutes. Intervention includes catheter repositioning or reinsertion, either by open surgical method or laparoscopically'}], 'secondaryOutcomes': [{'measure': 'Time to catheter dysfunction requiring intervention', 'timeFrame': 'One year', 'description': 'see above'}, {'measure': 'Dialysis catheter migration with dysfunction', 'timeFrame': 'One year', 'description': 'Dialysis catheter tip located above the pelvic brim on the abdominal radiograph'}, {'measure': 'Infusion pain', 'timeFrame': 'One month', 'description': 'Patient will be questioned on infusion pain around one month after starting peritoneal dialysis'}, {'measure': 'Risk of peritonitis', 'timeFrame': 'One year'}, {'measure': 'Technique failure', 'timeFrame': 'One year'}, {'measure': 'Peritoneal dialysis catheter survival', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['End-stage Renal Disease', 'Renal Failure']}, 'referencesModule': {'references': [{'pmid': '31445925', 'type': 'DERIVED', 'citation': 'Chow KM, Wong SSM, Ng JKC, Cheng YL, Leung CB, Pang WF, Fung WWS, Szeto CC, Li PKT. Straight Versus Coiled Peritoneal Dialysis Catheters: A Randomized Controlled Trial. Am J Kidney Dis. 2020 Jan;75(1):39-44. doi: 10.1053/j.ajkd.2019.05.024. Epub 2019 Aug 21.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the result of straight versus coiled Tenckhoff catheters for peritoneal dialysis patients. Recent meta-analysis of the peritoneal dialysis catheter type was in favor of straight catheters. The effects of straight versus coiled peritoneal dialysis catheters, however, are unclear. The investigators design an adequately powered randomized controlled study to evaluate the two types of double-cuffed peritoneal dialysis catheters. The primary objective is to assess whether straight peritoneal dialysis catheters can reduce the risk of catheter dysfunction that requires intervention. The investigators estimate that they would need to enroll 132 incident peritoneal dialysis patients in each group for the study to have 80% power to detect a difference between 7% and 15% in the primary endpoint of catheter dysfunction requiring intervention.', 'detailedDescription': 'The objective of the present study is to evaluate the a priori hypothesis that straight peritoneal dialysis catheters would improve the treatment outcomes of peritoneal dialysis. The early and late catheter complications, as well as catheter survival, will be compared between peritoneal dialysis patients who are randomized to straight and coiled Tenckhoff catheters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* requires dialysis catheter insertion for maintenance peritoneal dialysis\n* aged 18 or older\n* willingness to give written consent and comply with the study protocol\n\nExclusion Criteria:\n\n* known contraindication to peritoneal dialysis\n* participation in another interventional study within last 30 days of randomization\n* history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the dialysis procedures"}, 'identificationModule': {'nctId': 'NCT02479295', 'briefTitle': 'Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Randomized Controlled Trial of Straight Versus Coiled Peritoneal Dialysis', 'orgStudyIdInfo': {'id': '2015.197-T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Straight Tenckhoff catheter', 'description': 'Tenckhoff catheter with straight intra-abdominal part', 'interventionNames': ['Device: Tenckhoff catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Coiled Tenckhoff catheter', 'description': 'Tenckhoff catheter with coiled intra-abdominal part', 'interventionNames': ['Device: Tenckhoff catheter']}], 'interventions': [{'name': 'Tenckhoff catheter', 'type': 'DEVICE', 'otherNames': ['peritoneal dialysis catheter'], 'description': 'Peritoneal dialysis catheters for long term use', 'armGroupLabels': ['Coiled Tenckhoff catheter', 'Straight Tenckhoff catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SAR', 'city': 'Shatin', 'state': 'New Territories', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital, Chinese University of Hong Kong', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'city': 'Tai Po', 'country': 'Hong Kong', 'facility': 'Alice Ho Miu Ling Nethersole Hospital', 'geoPoint': {'lat': 22.45007, 'lon': 114.16877}}], 'overallOfficials': [{'name': 'Kai Ming Chow, MBChB, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Chow Kai Ming', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}