The CAP Study
Research type
Research Study
Full title
Clinical Evaluation, of an Antimicrobial – Impregnated Catheter Against Peritonitis
IRAS ID
333587
Contact name
Maarten Taal
Contact email
Sponsor organisation
University Hospitals of Derby & Burton NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
Peritoneal dialysis (PD) is a type of dialysis used to treat people with kidney failure. To perform PD, a silicone tube is placed with one end in the abdominal cavity and the other end exiting through the skin. Fluid is run into the abdomen via the tube and then drained out again after 1-4 hours. While in the abdomen, toxins and other waste chemicals move from the body into the fluid and are then removed when it is drained out. In this way, PD partially replaces kidney function.
Infection related to the tube is the most common risk associated with PD. This may be mild, but can be severe if the infection spreads to the abdominal cavity (peritonitis). Peritonitis may cause severe pain and even life-threatening sepsis. This requires urgent treatment with antibiotics and often admission to hospital.
Currently the only measures available to prevent PD tube infections are careful hygiene when handling the tube and antibiotics given before the tube is placed, or if there is concern that the tube has been contaminated. Despite these measures, peritonitis is one of the most common causes of people having to stop PD and change to another form of dialysis. There is therefore an urgent need to develop new ways to prevent PD tube infections.
We propose to test a PD tube with three different antibiotics introduced into the silicone. Similar tubes have been used in patients who have a particular type of brain surgery, in these patients the risk of infection was reduced by 60%.
We will study 40 people needing PD who will have the antibiotic-treated tubes placed as part of their normal care. This feasibility study will focus on checking whether the tubes are safe to use and, importantly, are acceptable to patients. This will inform future trial design.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0340
Date of REC Opinion
20 Dec 2023
REC opinion
Further Information Favourable Opinion