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NCT Number: NCT02479295

Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients

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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Failure Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tenckhoff catheter

Device

Peritoneal dialysis catheters for long term use

Other names: peritoneal dialysis catheter

Primary outcomes

  1. Incidence of catheter dysfunction that requires intervention

    Time frame: 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 outcomes

  1. Time to catheter dysfunction requiring intervention

    Time frame: One year

    see above

  2. Dialysis catheter migration with dysfunction

    Time frame: One year

    Dialysis catheter tip located above the pelvic brim on the abdominal radiograph

  3. Infusion pain

    Time frame: One month

    Patient will be questioned on infusion pain around one month after starting peritoneal dialysis

  4. Risk of peritonitis

    Time frame: One year

  5. Technique failure

    Time frame: One year

  6. Peritoneal dialysis catheter survival

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Randomized Controlled Trial of Straight Versus Coiled Peritoneal Dialysis

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 24, 2015
Registry last updated
Jan 28, 2021

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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