Peritoneal Dialysis Catheter Function

Peritoneal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347592
• Other study ID #: UHUmea01
• Status: Completed
• Phase: N/A
• First received: December 10, 2014
• Last updated: January 21, 2015
• Start date: November 2007
• Est. completion date: August 2014

Study information

• Verified date: January 2015
• Source: University Hospital, Umeå
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Peritoneal Dialysis

Intervention

Device:
• Self-locating Catheter
Procedure/Surgery necessary if obstruction occurs
• straight Tenckhoff
Procedure/Surgery necessary if obstruction occurs

Locations

Country	Name	City	State
Sweden	Medicincenter, Norrlands Universitetssjukhus	Umea

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Umeå

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insufficient drainage/flow of dialysis fluid that unabled adequate dialysis		12 Months	Yes