• Michael V Rocco, John T Daugirdas, Tom Greene, Robert S Lockridge, Christopher Chan, Andreas Pierratos, Robert Lindsay, Brett Larive, Glenn M Chertow, Gerald J Beck, Paul W Eggers, Alan S Kliger, and FHN Trial Group.
• Department of Medicine, Wake Forest University, Winston-Salem, NC. Electronic address: mrocco@wakehealth.edu.
• Am. J. Kidney Dis. 2015 Sep 1; 66 (3): 459-68.

BackgroundFew data are available regarding the long-term mortality rate for patients receiving nocturnal home hemodialysis.Study DesignPosttrial observational study.Setting & ParticipantsFrequent Hemodialysis Network (FHN) Nocturnal Trial participants who consented to extended follow-up.InterventionThe 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.Outcomes & MeasurementsWe 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.ResultsMedian 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).LimitationsThese 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.ConclusionsPatients 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.Copyright © 2015 National Kidney Foundation, Inc. All rights reserved.

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