Clinical Trials Directory

Trials / Completed

CompletedNCT02347592

Peritoneal Dialysis Catheter Function

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
62 (actual)
Sponsor
University Hospital, Umeå · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICESelf-locating CatheterProcedure/Surgery necessary if obstruction occurs
DEVICEstraight TenckhoffProcedure/Surgery necessary if obstruction occurs

Timeline

Start date
2007-11-01
Primary completion
2014-05-01
Completion
2014-08-01
First posted
2015-01-27
Last updated
2015-01-27

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT02347592. Inclusion in this directory is not an endorsement.