Peritoneal Dialysis Catheter Function
Comparison of Self-locating Catheter Versus a Straight Catheter for Outflow Problems.
1 other identifier
interventional
62
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 10, 2014
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedJanuary 27, 2015
January 1, 2015
6.5 years
December 10, 2014
January 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
insufficient drainage/flow of dialysis fluid that unabled adequate dialysis
12 Months
Study Arms (2)
straight Tenckhoff
ACTIVE COMPARATORThe straight Tenckhoff catheter (sT) is the most common used catheter for peritoneal dialysis (PD).
self-locating catheter
ACTIVE COMPARATORA new, more expensive, self-locating catheter (sLC) has been developed by Di Paolo.
Interventions
Eligibility Criteria
You may qualify if:
- All consecutive patients that are eligible and planned to start peritoneal dialysis and thereafter accept to be part of the study.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medicincenter, Norrlands Universitetssjukhus
Umeå, Sweden
Related Publications (3)
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: 15335150BACKGROUNDBriggs 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: 36810986DERIVEDStegmayr 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.
PMID: 26632891DERIVED
Study Officials
- STUDY CHAIR
Ragnberth Helleday, MD
Medicincenter, Norrlands Universitetssjukhus, Umea, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 10, 2014
First Posted
January 27, 2015
Study Start
November 1, 2007
Primary Completion
May 1, 2014
Study Completion
August 1, 2014
Last Updated
January 27, 2015
Record last verified: 2015-01