End-stage Renal Disease, Renal Failure
Conditions
Brief summary
This study compares the result of straight versus coiled Tenckhoff catheters for peritoneal dialysis patients. Recent meta-analysis of the peritoneal dialysis catheter type was in favor of straight catheters. The effects of straight versus coiled peritoneal dialysis catheters, however, are unclear. The investigators design an adequately powered randomized controlled study to evaluate the two types of double-cuffed peritoneal dialysis catheters. The primary objective is to assess whether straight peritoneal dialysis catheters can reduce the risk of catheter dysfunction that requires intervention. The investigators estimate that they would need to enroll 132 incident peritoneal dialysis patients in each group for the study to have 80% power to detect a difference between 7% and 15% in the primary endpoint of catheter dysfunction requiring intervention.
Detailed description
The objective of the present study is to evaluate the a priori hypothesis that straight peritoneal dialysis catheters would improve the treatment outcomes of peritoneal dialysis. The early and late catheter complications, as well as catheter survival, will be compared between peritoneal dialysis patients who are randomized to straight and coiled Tenckhoff catheters.
Interventions
DEVICETenckhoff catheter
Peritoneal dialysis catheters for long term use
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
straight versus coiled Tenckhoff catheters
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* requires dialysis catheter insertion for maintenance peritoneal dialysis * aged 18 or older * willingness to give written consent and comply with the study protocol
Exclusion criteria
* known contraindication to peritoneal dialysis * participation in another interventional study within last 30 days of randomization * history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the dialysis procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of catheter dysfunction that requires intervention | One year | Catheter dysfunction refers to drainage failure, as defined by the inability to drain peritoneal dialysate effluent reliably within 45 minutes. Intervention includes catheter repositioning or reinsertion, either by open surgical method or laparoscopically |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis catheter migration with dysfunction | One year | Dialysis catheter tip located above the pelvic brim on the abdominal radiograph |
| Infusion pain | One month | Patient will be questioned on infusion pain around one month after starting peritoneal dialysis |
| Time to catheter dysfunction requiring intervention | One year | see above |
| Technique failure | One year | — |
| Peritoneal dialysis catheter survival | One year | — |
| Risk of peritonitis | One year | — |
Countries
Hong Kong
Outcome results
None listed