Baseline characteristics of participants in the Frequent Hemodialysis Network (FHN) daily and nocturnal trials

Michael V. Rocco, Brett Larive, Paul W. Eggers, Gerald J. Beck, Glenn M. Chertow, Nathan W. Levin, Alan S. Kliger

Research output: Contribution to journalArticlepeer-review

42 Scopus citations

Abstract

Background: The annual mortality rate for maintenance hemodialysis patients in the United States is unacceptably high at 15%-20%. In 2004, we initiated the Frequent Hemodialysis Network (FHN) clinical trials. This report presents baseline characteristics of FHN Trial participants and compares them with hemodialysis patients tracked in US Renal Data System (USRDS) data. Study Design 2 separate randomized clinical trials. Settings & Participants FHN includes 332 patients with chronic kidney disease requiring long-term dialysis therapy enrolled in 2 separate randomized clinical trials. The FHN Daily Trial (245 randomly assigned participants) was designed to compare outcomes of 6-times-weekly in-center daily hemodialysis (1.5-2.75 h/session) with conventional 3-times-weekly in-center hemodialysis. The FHN Nocturnal Trial (87 randomly assigned participants) was designed to compare outcomes of 6-times-weekly home nocturnal (6-8 h/session) with conventional 3-times-weekly hemodialysis. USRDS data include 338,109 incident and prevalent long-term hemodialysis patients from the calendar year 2007. Results Participants in both trials were on average younger than the average hemodialysis patient in the United States (Daily Trial, 50.4 years; P < 0.001; Nocturnal Trial, 52.8 years; P < 0.001). Compared with USRDS data, whites were under-represented in the Daily Trial (36% vs 55%; P < 0.001), whereas Hispanics were under-represented in the Nocturnal Trial and over-represented in the Daily Trial (0% vs 28%; P < 0.001). In addition, there were more fistulas and fewer catheters in the Daily Trial (61% and 20%, respectively; P < 0.001 for both) and fewer grafts and more catheters in the Nocturnal Trial (10% and 44%, respectively; P < 0.005 for both). Limitations Clinical trial exclusion criteria and patient willingness to participate limit comparisons with the USRDS. Conclusions FHN participants were younger and the racial composition for each study was different from the racial composition of the aggregate US dialysis population. Catheters for vascular access were more common in FHN Nocturnal Trial participants.

Original languageEnglish
Pages (from-to)90-100
Number of pages11
JournalAmerican Journal of Kidney Diseases
Volume57
Issue number1
DOIs
StatePublished - Jan 2011
Externally publishedYes

Keywords

  • Frequent hemodialysis
  • daily hemodialysis
  • left ventricular hypertrophy
  • nocturnal hemodialysis
  • physical functioning
  • randomized clinical trial

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