Dialysis mortality is exceedingly high and even higher so in diabetic patients who now account for nearly 50% of incident patients. Attempts to reduce mortality have included higher doses of dialysis, use of more permeable dialyzers, better control of lipids and hypertension, use of pleiotrophic drugs such as ACEs and ARBS, control of oxidative stress and inflammation., improvement in hemoglobin control, choice of accesses, longer dialysis time, salt restriction, exercise, control of calcium and phosphorus metabolism and other approaches. Current 3X week dialysis is limited by the inability to remove small molecules because of reduced efficiency after a few hours and large molecules. Excess fluid cannot be adequately removed because of limited time available and of a relatively narrow range of permeability of dialyzer membranes. A method which is closer operationally to normal renal function is daily dialysis where the efficiency of the dialysis provided more frequently for somewhat shorter times is greater than the 3X week methods. It is expected that increased removal of uremic toxins will result in better outcomes although little evidence exists for any but the association with urea. Just as likely is the potential to control fluid volume so as to approach """"""""dry weight"""""""" and consequent better control of blood pressure with more frequent treatment times. With twice the opportunity to control target weight and the possibility of reduced interdialytic weight gain, ultrafiltration rates should fall and hypotensive episodes and quality of life improve. The new proposal will take the current daily dialysis study into a phase where all involved will have benefited from knowledge of this important information gathered so far. Enrollment started in January 2006 and the Vanguard phase of the study started June 1, 2006 and was completed on May 31, 2007. Total number of enrolled patients was 79, 17 of whom were withdrawn, 54 randomized and 8 still in baseline. Enrollment continues past the Vanguard phase and as of October 2007 total number of patients enrolled in RRI consortium is 99, 21 were excluded prior to randomization, 64 were successfully randomized, 37 completed 12 month therapy and 27 are still at the different time points of the treatment periods, 14 remain in baseline. The current proposal has permitted the participating sites to benefit from the knowledge gained and to begin offering it widely. The new proposal continues the project utilizing the experience to improve adherence of the daily dialysis patient.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK066579-07
Application #
7904282
Study Section
Special Emphasis Panel (ZDK1-GRB-N (J1))
Program Officer
Eggers, Paul Wayne
Project Start
2003-09-30
Project End
2011-01-31
Budget Start
2010-02-01
Budget End
2011-01-31
Support Year
7
Fiscal Year
2010
Total Cost
$350,000
Indirect Cost
Name
Renal Research Institute (Joint Venture)
Department
Type
DUNS #
931622732
City
New York
State
NY
Country
United States
Zip Code
10128
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