Nutritional outcomes from a randomised investigation of intradialytic oral nutritional supplements in patients receiving haemodialysis, (NOURISH): a protocol for a pilot randomised controlled trial

ABSTRACT: Haemodialysis is a form of renal replacement therapy but is a catabolic process that not only filters toxins but is also known to lead to amino acid losses. Patients with chronic kidney disease often have a poor appetite and this in combination with limited dietary intake and the detrimental effects of haemodialysis can lead to the development of malnutrition. Between 20% and 50% of haemodialysis patients are thought to be malnourished. Malnutrition can worsen clinical outcomes and increase the risk of hospitalisation. We hypothesise that a nutritional supplement taken during haemodialysis may help to improve nutritional status. The aim of this study is to conduct a pilot randomised controlled trial to assess the use of an intradialytic nutritional supplement on nutritional status. The objectives are to assess the feasibility of the trial including: recruitment and retention of participants; preference of nutritional supplements; compliance with the intervention; ease of completion of the questionnaires and appropriateness of the tools used. Secondary outcomes include clinical outcomes to obtain variance in the patient population and estimates of effect size to inform the sample size for a future definitive trial. The trial is a single centre, randomised, parallel-group, two armed external pilot with an intervention and control group. The intervention group will take a nutritional supplement each dialysis session from a choice of prescribable drink or pudding style supplements. The control group will receive standard care. Recruitment and feasibility elements are the primary outcomes. Recruitment will be to time (t = 6 weeks). In order to collect sufficient data to inform a future sample size calculation, we will aim to recruit 30 participants to obtain 12 evaluable per arm anticipating some drop out. Secondary outcome measures include clinical variables; hand grip strength, quality of life, weight and biochemistry completed at baseline, 1 and 2 months. Descriptive statistics will be used to analyse the baseline characteristics of the recruited participants. Means, confidence intervals and standard deviations will be reported for the outcome measures of handgrip strength, dietary intake, quality of life and weight. TRIAL REGISTRATION: ISRCTN37431579.