(Directly taken from the application) The gross mortality of patients in the United States (U.S.) with end- stage renal disease (ESRD) treated by hemodialysis (HD) has increased over the past decade. Patients treated by HD have a life expectancy of only 20 percent of the general population at the current mortality rate. The variables associated with morbidity and mortality must include those which are treatment related (amount of dialysis delivered, membrane type) and those which are patient related (age, gender, comorbid illness), yet these variables have not been prospectively evaluated in a large population. The goal of this project is to conduct a prospective, multi-center, randomized clinical trial which will examine the impact of different levels of dialysis dose and membrane composition upon the mortality and morbidity of HD patients. The experimental design is a two-by-two factorial study. Following a series of screening tests, including assessing the ability of delivering the high dose level of dialysis to each prospective participant, participants will be randomized to receive one of two levels of dialysis as measured by 2- pool variable volume KT/V: 0.95 vs 1.4, and to be dialyzed against either low flux cellulosic membranes or high flux synthetic or semisynthetic membranes. Mortality in each of the four groups will be the primary outcome. A series of secondary outcomes including hospitalization frequency, assessment of infectious and cardiac complications, nutritional and general health and morbidity assessment will also be evaluated. Stop points include inadequate dialysis, adverse reaction to the dialysis membrane, transplantation and conclusion of the follow-up period.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK046114-11
Application #
6380771
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Kusek, John W
Project Start
1992-09-30
Project End
2003-08-31
Budget Start
2001-09-01
Budget End
2003-08-31
Support Year
11
Fiscal Year
2001
Total Cost
$159,254
Indirect Cost
Name
Vanderbilt University Medical Center
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37212
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