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NOURISH: Nutritional Outcomes from a Randomised Investigation of Intradialytic Oral Nutritional Supplements in Patients Receiving Haemodialysis. A Pilot Randomised controlled trial.
Jackson, L. (1) Sully, B. (2) Cohen, J. (2) and Julious, S. (2)
Northern General Hospital, Sheffield teaching Hospitals NHS Foundation Trust, Sheffield.
Introduction
Malnutrition is reported to affect 20% - 50% of the haemodialysis population. Causes are multifactorial but include poor appetite and the catabolic effect of dialysis. Nutrition support interventions are known to improve measures of nutritional status but the most effective methods of support and the outcome measures to use to validate their efficacy have not been confirmed to date.
Methods
NOURISH is a two arm randomised, parallel group, external pilot trial of intradialytic oral nutritional supplements (ONS) during haemodialysis (HD) versus standard care. Eligible participants (HD patients ≥18 years, dialysis 3 times per week for at least last 6 months, Body Mass Index ≤22 kg/m2) were randomised to either receive an ONS each haemodialysis session or standard care for 2 months, stratified by gender and age.
Primary outcomes were recruitment and feasibility: recruitment rate (recruit to time, t = 6 weeks), barriers, data completion, and acceptability of assessment methods. Secondary outcome measures included palatability of supplements, oral intake (dietary recall), handgrip strength (dynamometry) and quality of life (QOL) using SF-12 completed at baseline, 1 and 2 months. The trial was designed to help inform the feasibility of a larger study, timing of assessments, and sample size requirements.
Results
10 participants were recruited, 5 randomised to each arm, representing 4% of the screened population. 7.2% of the screened population were eligible to participate but declined mainly due to a dislike of ONS. The main reason for ineligibility was a body mass index greater than 22kg/m2. Average time for monthly assessments was 35 to 55 minutes, which patients found acceptable. The completion of the session questionnaire to identify food intake on HD and ONS preferences had a completion rate of just 23.1%.
Significance tests were not performed for secondary outcome measures due to small sample size. 181 participants would be needed to identify a significant change in handgrip strength in a definitive trial based on 90% power and a minimally clinically important difference of 4Kg, requiring 10 centres of approximately 250 HD patients, recruiting for x time.
Conclusion
A definitive trial would be feasible in the UK, but some aspects need further consideration. Inclusion criteria - possibly increase BMI to 24kg/m2 and use additional measures of muscle mass to better indicate nutritional status. Timing of ONS during the intradialytic period should be clearly defined. Monthly assessments of oral intake, QOL, weight and routine blood results are advised but the use of session questionnaires is not indicated.