The role of the dietitian in a multicenter clinical trial of dialysis therapy: the Hemodialysis (HEMO) Study.

The Hemodialysis (HEMO) Study is a randomized multicenter prospective clinical trial, supported by the National Institute of Diabetes, Digestive, and Kidney Diseases of the National Institutes of Health. The trial is designed to assess the effects of a standard versus higher dialysis dose and low versus high dialysis membrane flux on morbidity and mortality of chronic hemodialysis patients. The role of the dietitian in the HEMO Study is to support and maintain the nutritional status of randomized participants. To ensure participant safety, nutritional status is closely monitored by a variety of biochemical and participant-reported parameters. Serum albumin and equilibrated normalized protein catabolic rates are obtained monthly. Appetite assessment and dietary energy and protein intakes using a 2-day diet diary assisted recall are ascertained at baseline and on a yearly basis. Consumption of vitamins, minerals, and nutritional supplements, including oral enterals, tube feedings, and parenteral nutrition, is obtained at least once a year. In addition, anthropometry is performed at baseline and on a yearly basis. Prespecified changes in serum albumin level or body weight trigger action by the dietitian to prevent protein calorie malnutrition. The HEMO Study dietitians play a vital role in carrying out the nutrition program for the trial. The HEMO Study should provide important information about the natural history of the nutritional status of chronic hemodialysis patients and the impact of dialysis dose and dialysis membrane flux on these parameters.