Extrait

Background and study aims Haemodialysis is a form of renal replacement therapy that clears the blood of toxins when a person’s own kidneys are unable to do so. The haemodialysis process unfortunately also filters out the building blocks of protein and uses energy. Patients with kidney disease often have a poor appetite and limited dietary intake because of their kidney problems and this in combination with the effects of haemodialysis can lead to the development of malnutrition. Studies have shown between 20% and 50% of haemodialysis patients to be malnourished and malnutrition can worsen clinical outcomes and increase the risk of hospitalisation. This is an initial study to assess the use of an intradialytic (meaning whilst on haemodialysis) nutritional supplement on nutritional status and whether this works better than normal care. Who can participate? Participants must be over the age of 18, receive regular haemodialysis and have a measure of height for weight that is lower than advised for a person receiving haemodialysis. What does the study involve? Participants are randomly allocated to one of two groups: an intervention and a control group. The intervention group will take a nutritional supplement each dialysis session from a choice of drinks or puddings in various flavours. The control group will receive standard care. Each group will complete a short questionnaire about their wellbeing each time they attend haemodialysis. They will have their hand grip strength measured and fill in a Quality Of Life questionnaire, at the start and at 1 and 2 months. Their weight will also be recorded along with routine blood tests. What are the possible benefits and risks of participating? There may not be any benefit to the participants directly, in part due to the study being of very short duration but the results of the study may help to improve the nutritional wellbeing of people receiving haemodialysis in the future. The risks to people who participate are very small as nutritional supplements are routinely used with people who have kidney problems. Where is the study run from? The trial will be conducted on one haemodialysis unit in a Yorkshire hospital (UK). When is the study starting and how long is it expected to run for? The study will run between May and September 2013. Who is funding the study? The University of Sheffield (UK) Who is the main contact? Louise Jackson, Senior Renal Dietitian [email protected]

Critère d'inclusion

• Haemodialysis - a form of renal replacement therapy

Liens

• ictrp
• isrctn