The research program outlined in this application provides a mechanism for randomizing at least 60 patients on chronic hemodialysis (HI)) three times per week into the Mortality and Morbidity Hemodialysis Study (MMHD). The proposed program will be headquartered at the Piedmont Dialysis Center, Inc. (PDCI) of the Bowman Gray School of Medicine (BGSM) in Winston-Salem, North Carolina. Our chart review at PDCI has identified 301 active HI) patients, of whom 187 patients meet the criteria for the MMHD study. Approximately 50% of these patients have BGSM attendings, while the other 50% are patients of private nephrologists who have agreed to enroll their patients into the MMHD study. It is estimated that 50% of this group can be recruited into this study, providing 94 patients for the kinetic modelling session of the baseline period. In addition, 73 new patients began HD at PDCI last year, providing additional patients for the recruit to replace component of the study. In the unlikely event that we are unable to recruit the required number of patients at PDCI, we will recruit patients from the BGSM owned Lexington and Mount Airy dialysis units. These two units presently have 110 active HD patients. All of these BGSM owned dialysis centers are state of the art facilities equipped with Baxter 550 hemodialysis machines, capable of a maximum blood flow rate of 600 ml/min and a maximum dialysis flow rate of 700 ml/min. All water is processed according to AAMI standards and reprocessing is performed using automated Renalin equipment. The staff at these dialysis centers have participated in both hemodialysis and peritoneal dialysis clinical research protocols. The proposed study will be conducted by two nephrologists who are on the full time faculty at BGSM who have experience in the care of patients with end-stage renal disease and in the operation of clinical trials. Both nephrologists were Co-Investigators for the MDRD study and served on MDRD subcommittees. The study coordinator has 8 years of experience as a dialysis nurse and was the study coordinator for an observational hemodialysis study performed at PDCI and its satellite units. The dietitian was one of three dietitians in the MDRD study at BGSM and she is certified by the DCC of the MDRD study in both anthropometry and food record documentation. In addition, our center was very successful in recruiting and retaining patients in the MDRD study. We recruited 61 patients, the second largest number among the 15 clinical centers, and had only two patients who were lost to follow-up.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project--Cooperative Agreements (U01)
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Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Kusek, John W
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Wake Forest University Health Sciences
Internal Medicine/Medicine
Schools of Medicine
United States
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