Michael V Rocco1, John T Daugirdas2, Tom Greene3, Robert S Lockridge4, Christopher Chan5, Andreas Pierratos6, Robert Lindsay7, Brett Larive8, Glenn M Chertow9, Gerald J Beck8, Paul W Eggers10, Alan S Kliger11. 1. Department of Medicine, Wake Forest University, Winston-Salem, NC. Electronic address: mrocco@wakehealth.edu. 2. Department of Medicine, University of Illinois at Chicago, Chicago IL. 3. Department of Biostatistics, University of Utah School of Medicine, Salt Lake City, UT. 4. Lynchburg Nephrology Physicians, University of Virginia, Lynchburg, VA. 5. University Health Network, University of Toronto, Toronto, Ontario, Canada. 6. Humber River Hospital, University of Toronto, Toronto, Ontario, Canada. 7. London Health Sciences Center, London, Ontario, Canada. 8. Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH. 9. Stanford University School of Medicine, Stanford, CA. 10. National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD. 11. Yale New Haven Hospital and Yale School of Medicine, New Haven, CT.
Abstract
BACKGROUND: Few data are available regarding the long-term mortality rate for patients receiving nocturnal home hemodialysis. STUDY DESIGN: Posttrial observational study. SETTING & PARTICIPANTS: Frequent Hemodialysis Network (FHN) Nocturnal Trial participants who consented to extended follow-up. INTERVENTION: 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. OUTCOMES & MEASUREMENTS: 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). LIMITATIONS: 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.
RCT Entities:
BACKGROUND: Few data are available regarding the long-term mortality rate for patients receiving nocturnal home hemodialysis. STUDY DESIGN: Posttrial observational study. SETTING & PARTICIPANTS: Frequent Hemodialysis Network (FHN) Nocturnal Trial participants who consented to extended follow-up. INTERVENTION: 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 Nocturnalparticipants were free to modify their hemodialysis prescription. OUTCOMES & MEASUREMENTS: 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). LIMITATIONS: 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.
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