Ten major hospitals across the United Kingdom are participating in the clinical trial of a breakthrough medical device that could improve the diagnosis and treatment of life-threatening peritonitis for patients undergoing peritoneal dialysis.
Developed over the past 5 years by MicroBioSensor, Manchester, UK, in collaboration with the peritoneal dialysis unit at Manchester Royal Infirmary, the QuickCheck device is intended to act as an early-warning system for peritonitis, and to provide guidance about the correct choice of antibiotic to treat the infection.
The trial will assess the efficacy of the device among cohorts of peritoneal dialysis patients who have and have not been infected with peritonitis. The trial is expected to last between 4 and 5 months. On successful completion of the study, MicroBioSensor will submit a CE mark application for QuickCheck, which will allow the company to launch the product in the United Kingdom and Europe.
“The team here at Sheffield are really pleased to be involved in this clinical study,” says Martin Wilkie, MD, FRCP, a consultant nephrologist at Sheffield Teaching Hospitals NHS Foundation Trust who is leading the study. “Trying to move testing nearer to the patient is key to improving patient care.”
Peritonitis is a life-threatening infection and is one of the most common complications for patients undergoing peritoneal dialysis. Prevention of peritonitis and prompt and appropriate management is essential for the long-term success of peritoneal dialysis in all patients. One in 20 peritonitis episodes results in the death of the patient, and patients have up to a 50% chance of contracting peritonitis for every year that they undergo peritoneal dialysis.
Peritonitis among peritoneal dialysis patients is currently diagnosed using the ‘cloudy effluent test,’ for which patients obtain a sample of their effluent and judge whether it is cloudy by attempting to read newsprint through it. The diagnosis is confirmed by a hospital-based test to count the leukocytes present in the dialysis fluid. If leukocyte levels have reached 100,000 cells per mL or more, peritonitis is confirmed. Unfortunately, this lengthy process means that the peritonitis infection has often already taken hold by the time of diagnosis, which can make effective treatment more difficult.
The QuickCheck device uses MicroBioSensor technology to detect high leukocyte or microbial cell levels, which indicate that the patient is developing peritonitis. Positive test results are signaled by a simple color change, which alerts healthcare staff of the infection. The results are available immediately at the end of an overnight dialysis session.
QuickCheck is able to flag an emerging infection at an early stage, and to confirm infective peritonitis without further delay. In addition, the test indicates whether the infection is sensitive to vancomycin, the front-line antibiotic most commonly prescribed for infective peritonitis, thereby providing guidance about the most effective antibiotic for treating the infection. This information is available to doctors as soon as the patient arrives at hospital for treatment.
For more information, visit MicroBioSensor.
