None listed
Conditions
Brief summary
Malnutrition is a critical issue affecting the quality of life of patients with end-stage kidney failure on dialysis, and is associated with chronic inflammation, adverse patient outcomes and increased death. Nutritional support is highly important in this patient group, but often oral supplements are insufficient to correct the malnourished state. Intradialytic parenteral nutrition (IDPN) is intravenous nutrition supplementation which is given during dialysis treatments. IDPN has had some promising effects on appetite, food intake, body weight and other markers of nutritional health, but needs to be studied more closely particularly before patients develop severe malnutrition. This multidisciplinary, collaborative project aims to compare IDPN versus standard dietetic input (control group) in malnourished dialysis patients, and look at the effect on a comprehensive range of key markers of nutrition and patient quality of life. We aim to address this important clinical problem, to obtain evidence for new therapeutic approaches to improve patient outcomes.
Interventions
500mls ClinOleic 20% Intradialytic Parental Nutrition will be administered whilst each subject is undergoing routine thrice-weekly haemodialysis. The IDPN bag will be connected by a tube to the venous chamber of the dialysis machine and the IDPN solution will be infused over the 4 hour dialysis session. Patients will receive the IDPN infusion during each dialysis session (three times a week) for 12 weeks. Blood pressure, blood glucose and tryglceride levels will be monitored during the period of
500mls ClinOleic 20% Intradialytic Parental Nutrition will be administered whilst each subject is undergoing routine thrice-weekly haemodialysis. The IDPN bag will be connected by a tube to the venous chamber of the dialysis machine and the IDPN solution will be infused over the 4 hour dialysis session. Patients will receive the IDPN infusion during each dialysis session (three times a week) for 12 weeks. Blood pressure, blood glucose and tryglceride levels will be monitored during the period of the intervention.
Sponsors
Central Northern Adelaide Renal and Transplant Unit
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
Undergoing maintenance haemodialysis AND BMI 19.8-22.9 plus serum albumin 25>35g/L or body weight loss 5-10% past 6 months
Exclusion criteria
Not undergoing maintenance haemodialysis, BMI< 19.8 or > 22.9, serum albumin >35g/L with < 5% body weight loss in the past 6 months, serum albumin <25g/L with body weight loss >10% in the past 6 months, egg or soy allergy, uncontrolled or untreated diabetes mellitus, Type I diabetes, diagnosis of malignancy, active infection, uncontrolled cardiac failure, liver failure, pancreatic insufficiency or other non-renal reason for malnutrition
Outcome results
None listed