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Completed

NCT Number: NCT02347592

Peritoneal Dialysis Catheter Function

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medicincenter, Norrlands Universitetssjukhus

Umeå, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-locating Catheter

Device

Procedure/Surgery necessary if obstruction occurs

straight Tenckhoff

Device

Procedure/Surgery necessary if obstruction occurs

Primary outcomes

  1. insufficient drainage/flow of dialysis fluid that unabled adequate dialysis

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

University Hospital, Umeå

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Jan 27, 2015
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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