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Peritoneal Dialysis Catheter Function

Comparison of Self-locating Catheter Versus a Straight Catheter for Outflow Problems.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02347592
Enrollment
62
Registered
2015-01-27
Start date
2007-11-30
Completion date
2014-08-31
Last updated
2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Dialysis

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.

Detailed description

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. Study 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. At 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. Outflow problems were defined as a delay of flow of more than 40 minutes for 500ml of PD fluid. The 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. Statistical analyses used were Breslow test and Kaplan Meier survival curve.

Interventions

DEVICESelf-locating Catheter

Procedure/Surgery necessary if obstruction occurs

DEVICEstraight Tenckhoff

Procedure/Surgery necessary if obstruction occurs

Sponsors

University Hospital, Umeå
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All consecutive patients that are eligible and planned to start peritoneal dialysis and thereafter accept to be part of the study.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
insufficient drainage/flow of dialysis fluid that unabled adequate dialysis12 Months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026