Frequent Hemodialysis Network Daily Trial (FHN Daily)
Number of Subjects in Study Archive: 245
Study Design: Interventional
Conditions: Dialysis, End Stage Renal Disease, Renal Insufficiency, Chronic
Duration: January 2006 – March 2010
# Recruitment Centers: 2
Treatment: Conventional hemodialysis; Frequent hemodialysiss
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: Yes
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT00264758
The FHN Daily Trial was a randomized controlled trial which recruited subjects from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 1 year. Subjects were randomized to either conventional hemodialysis delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week (120 patients), or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week (125 patients). The study had two co-primary outcomes: 1) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life scale.
To assess if more frequent hemodialysis resulted in better outcomes at 12 months.
The two coprimary composite outcomes were death or change (from baseline to 12 months) in left ventricular mass, as assessed by cardiac magnetic resonance imaging, and death or change in the physical-health composite score of the RAND 36-item health survey. Secondary outcomes included cognitive performance; self-reported depression; laboratory markers of nutrition, mineral metabolism, and anemia; blood pressure; and rates of hospitalization and of interventions related to vascular access.
End stage renal disease requiring chronic dialysis
Patients in the frequent-hemodialysis group averaged 5.2 sessions per week; the weekly standard Kt/V(urea) (the product of the urea clearance and the duration of the dialysis session normalized to the volume of distribution of urea) was significantly higher in the frequent-hemodialysis group than in the conventional-hemodialysis group (3.54±0.56 vs. 2.49±0.27). Frequent hemodialysis was associated with significant benefits with respect to both coprimary composite outcomes (hazard ratio for death or increase in left ventricular mass, 0.61; 95% confidence interval [CI], 0.46 to 0.82; hazard ratio for death or a decrease in the physical-health composite score, 0.70; 95% CI, 0.53 to 0.92). Patients randomly assigned to frequent hemodialysis were more likely to undergo interventions related to vascular access than were patients assigned to conventional hemodialysis (hazard ratio, 1.71; 95% CI, 1.08 to 2.73). Frequent hemodialysis was associated with improved control of hypertension and hyperphosphatemia. There were no significant effects of frequent hemodialysis on cognitive performance, self-reported depression, serum albumin concentration, or use of erythropoiesis-stimulating agents.
Frequent hemodialysis, as compared with conventional hemodialysis, was associated with favorable results with respect to the composite outcomes of death or change in left ventricular mass and death or change in a physical-health composite score but prompted more frequent interventions related to vascular access.