American Journal of Kidney Diseases
Volume 53, Issue 5 , Pages 835-844, May 2009

Solute Clearances and Fluid Removal in the Frequent Hemodialysis Network Trials

  • Tom Greene, PhD

      Affiliations

    • Corresponding Author InformationAddress correspondence to Tom Greene, PhD, Division of Epidemiology, University of Utah, 85 North Medical Drive, East Rm 201, Salt Lake City, UT 84112-5350
    • ,
  • John T. Daugirdas, MD
    • ,
  • Thomas A. Depner, MD
    • ,
  • Frank Gotch, MD
    • ,
  • Martin Kuhlman, MD
    • ,
  • Frequent Hemodialysis Network Study Group
    • ,
  • National Institute of Diabetes and Digestive and Kidney Diseases
    • ,
  • National Institutes of Health

National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD

Received 16 July 2008; accepted 26 December 2008. published online 02 April 2009.

Background

The Frequent Hemodialysis Network (FHN) is conducting 2 randomized clinical trials, a daytime in-center trial (“daily”) comparing 6 versus 3 treatments/wk, and a home nocturnal trial comparing 6 nocturnal treatments versus 3 conventional treatments/wk. The goal of this study was to project separation between the treatment and control arms of these studies for measures of dialysis dose by using simulations based on 2-compartment variable-volume models.

Setting & Participants

Data from the most recent hemodialysis treatment in 100 patients dialyzed 3 times/wk at facilities of the Renal Research Institute in New York and from 2 data sets (n = 154 and 115 patients) from the Hemodialysis (HEMO) trial.

Design

Observational study.

Predictor

Dialysis prescriptions for the treatment and control arms in the FHN trials.

Dialysis Regimen Outcomes

Treatment time, ultrafiltration rate, standard Kt/V/wk for urea (stdKt/Vurea), and continuous clearance estimates based on ratios of urea, creatinine, and normalized β2-microglobulin generation rates (denoted by Gn) to time-averaged concentrations (TACs) of these solutes during 1 treatment week.

Results

The expected differences between median values in the experimental and control groups were weekly treatment time: daily trial, 29%; nocturnal trial, 234%; ultrafiltration rate: daily, −20%; nocturnal, −69%; stdKt/Vurea: daily, 52%; nocturnal, 133%; Gnurea/TACurea: daily, 34%; nocturnal, 130%; Gncr/TACcr: daily, 31%; nocturnal, 135%; and Gnβ2/TACβ2: daily, 8%; nocturnal, 67%.

Limitations

Use of simulated data and assumption of equivalent volumes and ultrafiltration rates between treatment arms.

Conclusions

The nocturnal 6-times-weekly regimen produces substantially greater separation between the treatment and control arms than the daytime 6-times-weekly regimen for a wide range of treatment parameters. However, the 6-times-weekly interventions in both FHN trials will produce substantially greater separation than in the HEMO trial, where separations in median weekly treatment time and stdKt/Vurea between the 3-times-weekly high- and standard-dose groups were 18% and 17%, respectively. The FHN trials will test whether substantial increases in solute clearance and other effects of frequent hemodialysis materially influence selected intermediate outcome measures.

Index Words: Daily dialysis, nocturnal dialysis, kinetic modeling, clinical trials

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 Trial registration: www.clinicaltrials.gov; study numbers: NCT00264758 and NCT00271999.

 A list of the members of the Frequent Hemodialysis Network Study Group appears at the end of this article.

 Because the Editor-in-Chief recused himself from consideration of this manuscript, the Deputy Editor (Daniel E. Weiner, MD, MS, Tufts Medical Center) served as Acting Editor-in-Chief. Details of the journal's procedures for potential editor conflicts are given in the Editorial Policies section of the AJKD website.

 Originally published online as doi:10.1053/j.ajkd.2008.12.039 on April 2, 2009.

PII: S0272-6386(09)00401-6

doi:10.1053/j.ajkd.2008.12.039

American Journal of Kidney Diseases
Volume 53, Issue 5 , Pages 835-844, May 2009

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