This is an application from the Division of Nephrology at the Duke University Medical Center to participate as a clinical center in a NIH sponsored cooperative study aimed at reducing morbidity and mortality in patients with end-stage renal disease. This proposal focuses exclusively on patients receiving incenter hemodialysis and conforms to the criteria set forth in the NIH Guide entitled """"""""Morbidity and Mortality in Hemodialysis Patients"""""""". This trial is a prospective, multicenter, randomized, 2 X 2 factorial designed clinical trial. This trial is designed to compare two different classes of hemodialysis membranes and two levels of delivered dialysis (defined by the formula Kt/V, where K is the dialyzer urea clearance in ml/min, t is the treatment time in minutes, and V is the body urea volume in milliliters) on patient morbidity and mortality. The Kt/V delivered dialysis target in 50% of the patients will be 0.9-1.1. The Kt/V delivered dialysis target in the 50% of the patients will be 1.3-1.5. Within each of these delivered dialysis groups 50% of the patients will be dialyzed with a high-flux, biocompatible, dialysis membrane and 50% will be dialyzed with a low-flux, bioincompatible cellulosic membrane. The objectives of the study are to reduce mortality and morbidity in hemodialysis patients. The interventions will be the amount of delivered dialysis and the dialysis membrane employed. Mortality due to all causes will be the primary outcome. Secondary outcomes include rate of nonvascular access- related hospital admission, cardiovascular events, congestive heart failure, occurrence of infections, and decline in serum albumin. The role of the amount of delivered dialysis and the type dialysis membrane should be apparent by the end of the trial. The Duke University dialysis system proposes to enroll 60 patients into this multicenter protocol and comply with all aspects of the manual of operations.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01DK049244-01
Application #
2149909
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Project Start
1994-09-30
Project End
2001-08-31
Budget Start
1994-09-30
Budget End
1995-08-31
Support Year
1
Fiscal Year
1994
Total Cost
Indirect Cost
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705
Unruh, Mark L; Newman, Anne B; Larive, Brett et al. (2008) The influence of age on changes in health-related quality of life over three years in a cohort undergoing hemodialysis. J Am Geriatr Soc 56:1608-17
Unruh, Mark; Miskulin, Dana; Yan, Guofen et al. (2004) Racial differences in health-related quality of life among hemodialysis patients. Kidney Int 65:1482-91
Unruh, Mark; Yan, Guofen; Radeva, Milena et al. (2003) Bias in assessment of health-related quality of life in a hemodialysis population: a comparison of self-administered and interviewer-administered surveys in the HEMO study. J Am Soc Nephrol 14:2132-41
Miskulin, D C; Athienites, N V; Yan, G et al. (2001) Comorbidity assessment using the Index of Coexistent Diseases in a multicenter clinical trial. Kidney Int 60:1498-510