End-stage renal disease (ESRD) is associated with a markedly reduced patient survival and substantial morbidity. The life expectancy of a 40 year-old dialysis patient is 8.8 years, as compared with 37.4 years for the general U.S. population of the same age. Retrospective studies have suggested that higher Kt/V and use of dialysis membranes with higher flux and greater biocompatibility may decrease morbidity and mortality in maintenance hemodialysis patients, but few prospective studies have evaluated the effects of such manipulations. This prospective, randomized, multicenter investigation will test the following hypotheses: (1) Hemodialysis achieving higher Kt/V results in decreased mortality in ESRD patients undergoing maintenance hemodialysis. (2) Hemodialysis with membranes of higher flux decreases mortality and morbidity. (3) These two interventions are safe and acceptable to hemodialysis patients. In-center hemodialysis patients will be randomized to receive dialysis treatments with either standard or high Kt/V (1.0 vs 1.4, double pool) and using either high flux membranes or low flux membranes. Subjects will be randomized to one of four experimental groups: a. Kt/V 1.40; High flux membrane b. Kt/V 1.40; Low flux membrane c. Kt/V 1.00; High flux membrane d. Kt/V 1.00; Low flux membrane All other aspects of the patients' medical and dialysis care will follow the usual standards of care. The study subjects will be followed prospectively for five years to determine: a. Patient mortality (primary endpoint) b. Patient morbidity (secondary endpoint) i. Non-access related hospitalization (especially cardiovascular events or serious infections) ii. Malnutrition (a decline in serum albumin) The results will be analyzed to determine whether there are significant differences in patient survival or morbidity among the four treatment groups.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK049264-08
Application #
6380960
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Kusek, John W
Project Start
1994-09-30
Project End
2004-08-31
Budget Start
2001-09-01
Budget End
2004-08-31
Support Year
8
Fiscal Year
2001
Total Cost
$152,578
Indirect Cost
Name
University of Alabama Birmingham
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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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