Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-02 @ 6:05 AM
Study NCT ID:
NCT02347592
Status:
COMPLETED
Last Update Posted:
2015-01-27
First Post:
2014-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peritoneal Dialysis Catheter Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-21', 'studyFirstSubmitDate': '2014-12-10', 'studyFirstSubmitQcDate': '2015-01-21', 'lastUpdatePostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insufficient drainage/flow of dialysis fluid that unabled adequate dialysis', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peritoneal Dialysis']}, 'referencesModule': {'references': [{'pmid': '15335150', 'type': 'BACKGROUND', 'citation': 'Di Paolo N, Capotondo L, Sansoni E, Romolini V, Simola M, Gaggiotti E, Bercia R, Buoncristiani U, Canto P, Concetti M, De Vecchi A, Fatuzzo P, Giannattasio M, La Rosa R, Lopez T, Lo Piccolo G, Melandri M, Vezzoli G, Orazi E, Pacitti A, Ramello A, Russo F, Napoli M, Tessarin MC. The self-locating catheter: clinical experience and follow-up. Perit Dial Int. 2004 Jul-Aug;24(4):359-64.'}, {'pmid': '36810986', 'type': 'DERIVED', 'citation': 'Briggs VR, Jacques RM, Fotheringham J, Maheswaran R, Campbell M, Wilkie ME. Catheter insertion techniques for improving catheter function and clinical outcomes in peritoneal dialysis patients. Cochrane Database Syst Rev. 2023 Feb 22;2(2):CD012478. doi: 10.1002/14651858.CD012478.pub2.'}, {'pmid': '26632891', 'type': 'DERIVED', 'citation': 'Stegmayr BG, Sperker W, Nilsson CH, Degerman C, Persson SE, Stenbaek J, Arnerlov C. Few Outflow Problems With a Self-locating Catheter for Peritoneal Dialysis: A Randomized Trial. Medicine (Baltimore). 2015 Dec;94(48):e2083. doi: 10.1097/MD.0000000000002083.'}]}, 'descriptionModule': {'briefSummary': 'The straight Tenckhoff is the most common catheter for peritoneal dialysis. A new, more expensive,self-locating catheter with a heavy tip has been developed by Di Paolo. The investigators used these catheters in parallel for several years. To clarify what catheter has least problems the investigators performed a comparative study to clarify if outflow problems differed between these catheters.', 'detailedDescription': 'The straight Tenckhoff catheter (sT) is the most common used catheter for peritoneal dialysis (PD). A new, more expensive, self-locating catheter (sLC) has been developed by Di Paolo. The investigators had used both in parallel for several years. To clarify what catheter to focus on in the future the investigators performed a comparative study to clarify if outflow problems differed between these catheters.\n\nStudy design: interventional and randomized at the same hospital Patients: Patients that were planned to start PD were informed and asked to participate in the randomized study. All patients who were asked accepted and consented to be included in the investigation.\n\nAt the investigators hospital, insertion of pertitnoean dialysis catheters is performed by open surgery. This is performed using a three layer suture technique performed in local anesthesia. The technique enables immediate start of dialysis after surgery.\n\nOutflow problems were defined as a delay of flow of more than 40 minutes for 500ml of PD fluid.\n\nThe duration of time was calculated by months on PD. Patients who died, were transplanted or changed for hemodialysis were censored. End-point was an insufficient drainage/flow of dialysis fluid that unabled adequate dialysis and intervention (by surgery) was necessary to correct/change catheter.\n\nStatistical analyses used were Breslow test and Kaplan Meier survival curve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patients that are eligible and planned to start peritoneal dialysis and thereafter accept to be part of the study.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02347592', 'briefTitle': 'Peritoneal Dialysis Catheter Function', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Umeå'}, 'officialTitle': 'Comparison of Self-locating Catheter Versus a Straight Catheter for Outflow Problems.', 'orgStudyIdInfo': {'id': 'UHUmea01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'straight Tenckhoff', 'description': 'The straight Tenckhoff catheter (sT) is the most common used catheter for peritoneal dialysis (PD).', 'interventionNames': ['Device: straight Tenckhoff']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'self-locating catheter', 'description': 'A new, more expensive, self-locating catheter (sLC) has been developed by Di Paolo.', 'interventionNames': ['Device: Self-locating Catheter']}], 'interventions': [{'name': 'Self-locating Catheter', 'type': 'DEVICE', 'description': 'Procedure/Surgery necessary if obstruction occurs', 'armGroupLabels': ['self-locating catheter']}, {'name': 'straight Tenckhoff', 'type': 'DEVICE', 'description': 'Procedure/Surgery necessary if obstruction occurs', 'armGroupLabels': ['straight Tenckhoff']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Umeå', 'country': 'Sweden', 'facility': 'Medicincenter, Norrlands Universitetssjukhus', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Ragnberth Helleday, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medicincenter, Norrlands Universitetssjukhus, Umea, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Umeå', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bernd Stegmayr', 'investigatorAffiliation': 'University Hospital, Umeå'}}}}