Peritoneal Dialysis Catheter Function

University Hospital, Umeå

Status: Completed

Conditions: Peritoneal Dialysis

Treatments: Device: Self-locating Catheter; Device: straight Tenckhoff

Study type: Interventional

Funder types: Other

Identifiers

NCT02347592

UHUmea01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

straight Tenckhoff

Active Comparator group

Description:

The straight Tenckhoff catheter (sT) is the most common used catheter for peritoneal dialysis (PD).

Treatment:

Device: straight Tenckhoff

self-locating catheter

Active Comparator group

Description:

A new, more expensive, self-locating catheter (sLC) has been developed by Di Paolo.

Treatment:

Device: Self-locating Catheter