title: Long-term Effects of Frequent Nocturnal Hemodialysis on Mortality: The Frequent Hemodialysis Network (FHN) Nocturnal Trial.
abstract: BACKGROUND
  Few data are available regarding the long-term mortality rate for patients receiving nocturnal home hemodialysis.
  
  
  METHODS
  Posttrial observational study.
  
  
  METHODS
  Frequent Hemodialysis Network (FHN) Nocturnal Trial participants who consented to extended follow-up.
  
  
  METHODS
  The FHN Nocturnal Trial randomly assigned 87 individuals to 6-times-weekly home nocturnal hemodialysis or 3-times-weekly hemodialysis for 1 year. Patients were enrolled starting in March 2006 and follow-up was completed by May 2010. After the 1-year trial concluded, FHN Nocturnal participants were free to modify their hemodialysis prescription.
  
  
  METHODS
  We obtained dates of death and kidney transplantation through July 2011 using linkage to the US Renal Data System and queries of study centers. We used log-rank tests and Cox regression to relate mortality to the initial randomization assignment.
  
  
  RESULTS
  Median follow-up for the trial and posttrial observational period was 3.7 years. In the nocturnal arm, there were 2 deaths during the 12-month trial period and an additional 12 deaths during the extended follow-up. In the conventional arm, the numbers of deaths were 1 and 4, respectively. In the nocturnal dialysis group, the overall mortality HR was 3.88 (95% CI, 1.27-11.79; P=0.01). Using as-treated analysis with a 12-month running treatment average, the HR for mortality was 3.06 (95% CI, 1.11-8.43; P=0.03). Six-month running treatment data analysis showed an HR of 1.12 (95% CI, 0.44-3.22; P=0.7).
  
  
  CONCLUSIONS
  These results should be interpreted cautiously due to a surprisingly low (0.03 deaths/patient-year) mortality rate for individuals randomly assigned to conventional home hemodialysis, low statistical power for the mortality comparison due to the small sample size, and the high rate of hemodialysis prescription changes.
  
  
  CONCLUSIONS
  Patients randomly assigned to nocturnal hemodialysis had a higher mortality rate than those randomly assigned to conventional dialysis. The implications of this result require further investigation.
authors: Department of Medicine, Wake Forest University, Winston-Salem, NC. Electronic address: mrocco@wakehealth.edu.
authors: Michael V
authors: MV
authors: Rocco
authors: Department of Medicine, University of Illinois at Chicago, Chicago IL.
authors: John T
authors: JT
authors: Daugirdas
authors: Department of Biostatistics, University of Utah School of Medicine, Salt Lake City, UT.
authors: Tom
authors: T
authors: Greene
authors: Lynchburg Nephrology Physicians, University of Virginia, Lynchburg, VA.
authors: Robert S
authors: RS
authors: Lockridge
authors: University Health Network, University of Toronto, Toronto, Ontario, Canada.
authors: Christopher
authors: C
authors: Chan
authors: Humber River Hospital, University of Toronto, Toronto, Ontario, Canada.
authors: Andreas
authors: A
authors: Pierratos
authors: London Health Sciences Center, London, Ontario, Canada.
authors: Robert
authors: R
authors: Lindsay
authors: Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH.
authors: Brett
authors: B
authors: Larive
authors: Stanford University School of Medicine, Stanford, CA.
authors: Glenn M
authors: GM
authors: Chertow
authors: Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH.
authors: Gerald J
authors: GJ
authors: Beck
authors: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
authors: Paul W
authors: PW
authors: Eggers
authors: Yale New Haven Hospital and Yale School of Medicine, New Haven, CT.
authors: Alan S
authors: AS
authors: Kliger
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D002423:Cause of Death; D006437:Hemodialysis, Home / Q000379:methods; D057194:Intention to Treat Analysis; D007676:Kidney Failure, Chronic / Q000401:mortality / Q000628:therapy
keywords: Frequent Hemodialysis Network (FHN) Nocturnal Trial; Nocturnal hemodialysis; clinical trial; dialysis adequacy; dialysis dose; dialysis regimen; end-stage renal disease (ESRD); extended hemodialysis; frequent hemodialysis; frequent-long dialysis schedule; hemodialysis prescription; mortality; renal replacement therapy