• Takeshi Hasegawa, Shigeru Nakai, Ikuto Masakane, Yuzo Watanabe, Kunitoshi Iseki, Yoshiharu Tsubakihara, and Tadao Akizawa.
• Center for Innovative Research for Communities and Clinical Excellence, Fukushima Medical University, Fukushima, Japan; Division of Nephrology, Department of Internal Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan; Committee of Renal Data Registry, the Japanese Society for Dialysis Therapy, Tokyo, Japan. Electronic address: tahasegawa-npr@umin.net.
• Am. J. Kidney Dis. 2015 Jun 1; 65 (6): 899-904.

BackgroundThe quality of dialysis fluid water might play an important role in hemodialysis patient outcomes. Although targeted endotoxin levels of dialysis fluid vary among countries, evidence of the contribution of these levels to mortality in hemodialysis patients is lacking.Study DesignRetrospective cohort study using data from the Japan Renal Data Registry, a nationwide annual survey.Setting & Participants130,781 patients receiving thrice-weekly in-center hemodialysis for more than 6 months were enrolled at 2,746 facilities in Japan at the end of 2006. None of the patients changed facility or treatment modality during 2007.PredictorHighest endotoxin level in dialysis fluid reported by each facility during 2006. Patients were categorized by facility endotoxin level into the following groups: <0.001, 0.001 to <0.01, 0.01 to <0.05, 0.05 to <0.1, and ≥0.1EU/mL. Age, sex, dialysis vintage, diabetes mellitus as a primary cause of end-stage renal disease, Kt/V, normalized protein catabolic rate, dialysis session duration, serum albumin, and hemoglobin were measured as potential confounders.OutcomeAll-cause mortality, censored by transplantation; withdrawal from dialysis treatment; or end of follow-up.ResultsOf 130,781 hemodialysis patients, 91.2% had facility endotoxin levels below the limit set for dialysis fluid in Japan (<0.05EU/mL). During a 1-year follow-up, 8,978 (6.9%) patients died of all causes. The rate of all-cause mortality at 1 year was highest in the ≥0.1-EU/mL category (88.0 deaths/1,000 person-years). Patients in the ≥0.1-EU/mL group exhibited an increased risk of all-cause mortality of 28% (95% CI, 10%-48%) compared to the <0.001-EU/mL group.LimitationsEndotoxin level in dialysis fluid is reported as categorical data. No information about variation in endotoxin levels in dialysis fluid over time.ConclusionsHigher facility endotoxin levels in dialysis fluid may be related to increased risk for all-cause mortality among hemodialysis patients. Correcting this modifiable facility water management practice might improve the outcome of hemodialysis patients.Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

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