Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis
Garabed Eknoyan, M.D., Gerald J. Beck, Ph.D., Alfred K. Cheung, M.D., John T. Daugirdas, M.D., Tom Greene, Ph.D., John W. Kusek, Ph.D., Michael Allon, M.D., James Bailey, M.D., James A. Delmez, M.D., Thomas A. Depner, M.D., Johanna T. Dwyer, D.Sc., R.D., Andrew S. Levey, M.D., Nathan W. Levin, M.D., Edgar Milford, M.D., Daniel B. Ornt, M.D., Michael V. Rocco, M.D., Gerald Schulman, M.D., Steve J. Schwab, M.D., Brendan P. Teehan, M.D., Robert Toto, M.D., for the Hemodialysis (HEMO) Study Group
Background The effects of the dose of dialysis and the levelof flux of the dialyzer membrane on mortality and morbidityamong patients undergoing maintenance hemodialysis are uncertain.
Methods We undertook a randomized clinical trial in 1846 patientsundergoing thrice-weekly dialysis, using a two-by-two factorialdesign to assign patients randomly to a standard or high doseof dialysis and to a low-flux or high-flux dialyzer.
Results In the standard-dose group, the mean (±SD) urea-reductionratio was 66.3±2.5 percent, the single-pool Kt/V was1.32±0.09, and the equilibrated Kt/V was 1.16±0.08;in the high-dose group, the values were 75.2±2.5 percent,1.71±0.11, and 1.53±0.09, respectively. Flux,estimated on the basis of beta2-microglobulin clearance, was3±7 ml per minute in the low-flux group and 34±11ml per minute in the high-flux group. The primary outcome, deathfrom any cause, was not significantly influenced by the doseor flux assignment: the relative risk of death in the high-dosegroup as compared with the standard-dose group was 0.96 (95percent confidence interval, 0.84 to 1.10; P=0.53), and therelative risk of death in the high-flux group as compared withthe low-flux group was 0.92 (95 percent confidence interval,0.81 to 1.05; P=0.23). The main secondary outcomes (first hospitalizationfor cardiac causes or death from any cause, first hospitalizationfor infection or death from any cause, first 15 percent decreasein the serum albumin level or death from any cause, and allhospitalizations not related to vascular access) also did notdiffer significantly between either the dose groups or the fluxgroups. Possible benefits of the dose or flux interventionswere suggested in two of seven prespecified subgroups of patients.
Conclusions Patients undergoing hemodialysis thrice weekly appearto have no major benefit from a higher dialysis dose than thatrecommended by current U.S. guidelines or from the use of ahigh-flux membrane.
Source Information
From the Baylor College of Medicine, Houston (G.E.); the Cleveland Clinic Foundation, Cleveland (G.J.B., T.G.); the University of Utah and the Veterans Affairs Salt Lake City Health Care System, Salt Lake City (A.K.C.); the University of Illinois and the Veterans Affairs Chicago Health Care System, Chicago (J.T. Daugirdas); the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md. (J.W.K.); the University of Alabama at Birmingham, Birmingham (M.A.); Emory University Hospital, Atlanta (J.B.); Washington University, St. Louis (J.A.D.); the University of California at Davis, Sacramento (T.A.D.); New England Medical Center, Boston (J.T. Dwyer, A.S.L.); Beth Israel Medical Center, New York (N.W.L.); Brigham and Women's Hospital, Boston (E.M.); the University of Rochester, Rochester, N.Y. (D.B.O.); Wake Forest University, Winston-Salem, N.C. (M.V.R.); Vanderbilt University, Nashville (G.S.); Duke University, Durham, N.C. (S.J.S.); Lankenau Hospital and Medical Research Center, Wynnewood, Pa. (B.P.T.); and the University of Texas Southwestern Medical Center, Dallas (R.T.).
Address reprint requests to Dr. Beck at the HEMO Study Data Coordinating Center, Dept. of Biostatistics and Epidemiology, Wb4, Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, OH 44195, or at beckg{at}ccf.org.
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