Peritoneal Dialysis Catheter Function

January 21, 2015 updated by: Bernd Stegmayr, University Hospital, Umeå

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umea, Sweden
        • Medicincenter, Norrlands Universitetssjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: straight Tenckhoff
The straight Tenckhoff catheter (sT) is the most common used catheter for peritoneal dialysis (PD).
Device: straight Tenckhoff
Procedure/Surgery necessary if obstruction occurs
Active Comparator: self-locating catheter
A new, more expensive, self-locating catheter (sLC) has been developed by Di Paolo.
Device: Self-locating Catheter
Procedure/Surgery necessary if obstruction occurs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insufficient drainage/flow of dialysis fluid that unabled adequate dialysis
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Umeå

Investigators

  • Study Chair: Ragnberth Helleday, MD, Medicincenter, Norrlands Universitetssjukhus, Umea, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 21, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • UHUmea01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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