None listed
Conditions
Brief summary
During peritoneal dialysis fluid is repeatedly recycled in the abdomen, to get rid of excess fluid and waste products. Peritonitis or infection of the lining inside the abdomen is a serious complication in dialysis patients that can sometimes result in death, hospitalisation or withdrawal of peritoneal dialysis. We add antibiotics to the dialysis fluid which then dwell inside the abdomen. The dialysis process interferes with the ability of the body to localise infection and depletes useful factors formed to fight it. Icodextrin® is a product that can provide superior dialysis to the traditional dextrose based product that is used in our units, especially so with fluid removal during peritonitis episodes. It is our aim to utilise the superior dialytic properties of Icodextrin® in the first 60 hours following a peritonitis episode with a dialysis free period of up to 12 hours to allow the body sufficient time to contain the infection and also to allow sufficient build up of the factors of immunity to overcome the infection. We want to show that this procedure is equivalent in safety to the traditional treatment we use and is associated with less inflammation in the peritoneum and blood of patients.
Interventions
dialysis exchange free interval in peritoneal dialysis patients presenting with peritonitis , use of Intraperitoneal Icodextrin (2500mls of 7.5%) for dialysis in conjunction with dry exchanges for 2 days post peritonitis onset. thereafter patients continue as per standard treatment.Intraperitoneal antibiotics are added to one exhange /day.
Sponsors
A+ Trust fund
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 18 years or over Ability to give informed consent Diagnosis of End stage renal disease Subjects on Peritoneal dialysis for at least a month and has had a baseline PET study. Prevalent patients on peritoneal dialysis presenting with peritonitis (Dialysate white cell count- WCC > 100cells/HPF and > 50% polymorphonuclear leukocytes PMNL)
Exclusion criteria
Subjects with a severe mental disability or psychiatric disorder that interferes with their ability to give informed consent and /or comply with study procedures. Diabetic patients requiring insulin or using non-glucose oxidase based systems (Advantage) for blood sugar monitoring. Female subjects who are pregnant, lactating or planning to become pregnant. Note: female subjects of childbearing potential must not be pregnant or lactating and must be using a medically acceptable means of contraception. Peritonitis in the previous month. Subjects unable to receive inraperitoneal antibiotics for the treatment of their peritonitis. Previous hypersensitivity to Icodextrin® Subjects who have glycogen storage disease Subjects with maltose or isomaltose intolerance Chronically underdialysed patients with the most recent serum urea =35 mmol/l and a serum potassium = 5.8mmol/l. Subjects with mean arterial blood pressure (MAP) = 150 mm Hg on presentation. Subjects who have ongoing clinically significant congestive heart failure (New York heart Association Class III or IV) Subjects with concomitant participation in any other interventional study affecting PD solution prescription. Subjects who have any medical condition that, in the judgement of the investigators, would jeopardise the patient’s safety following exposure to the study drug or in the judgement of the investigators will not be able to tolerate the procedure.
Outcome results
None listed