title: Dialysis fluid endotoxin level and mortality in maintenance hemodialysis: a nationwide cohort study.
abstract: BACKGROUND
  The 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.
  
  
  METHODS
  Retrospective cohort study using data from the Japan Renal Data Registry, a nationwide annual survey.
  
  
  METHODS
  130,781 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.
  
  
  METHODS
  Highest 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.
  
  
  RESULTS
  All-cause mortality, censored by transplantation; withdrawal from dialysis treatment; or end of follow-up.
  
  
  RESULTS
  Of 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.
  
  
  CONCLUSIONS
  Endotoxin level in dialysis fluid is reported as categorical data. No information about variation in endotoxin levels in dialysis fluid over time.
  
  
  CONCLUSIONS
  Higher 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.
authors: 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.
authors: Takeshi
authors: T
authors: Hasegawa
authors: Committee of Renal Data Registry, the Japanese Society for Dialysis Therapy, Tokyo, Japan; Fujita Health University, Toyoake, Japan.
authors: Shigeru
authors: S
authors: Nakai
authors: Committee of Renal Data Registry, the Japanese Society for Dialysis Therapy, Tokyo, Japan; Yabuki Hospital, Yamagata, Japan.
authors: Ikuto
authors: I
authors: Masakane
authors: Committee of Renal Data Registry, the Japanese Society for Dialysis Therapy, Tokyo, Japan; Kasugai Municipal Hospital, Kasugai, Japan.
authors: Yuzo
authors: Y
authors: Watanabe
authors: Committee of Renal Data Registry, the Japanese Society for Dialysis Therapy, Tokyo, Japan; Faculty of Medicine, University of Ryukyus, Okinawa, Japan.
authors: Kunitoshi
authors: K
authors: Iseki
authors: Committee of Renal Data Registry, the Japanese Society for Dialysis Therapy, Tokyo, Japan; Graduate School of Medicine, Osaka University, Osaka, Japan.
authors: Yoshiharu
authors: Y
authors: Tsubakihara
authors: Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
authors: Tadao
authors: T
authors: Akizawa
mesh_terms: D000368:Aged; D015331:Cohort Studies; D004340:Drug Contamination / Q000706:statistics & numerical data*; D004731:Endotoxins / Q000032:analysis*; D005260:Female; D015312:Hemodialysis Solutions / Q000737:chemistry* / Q000592:standards; D006801:Humans; D007564:Japan; D007676:Kidney Failure, Chronic / Q000401:mortality / Q000628:therapy*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009026:Mortality; D016016:Proportional Hazards Models; D006435:Renal Dialysis; D012189:Retrospective Studies
chemical_list: D004731:Endotoxins; D015312:Hemodialysis Solutions
keywords: Hemodialysis (HD); Japan Renal Data Registry (JRDR); bacterial contamination; dialysis facility; dialysis fluid; end-stage renal disease (ESRD); endotoxin level; microbial contamination; mortality; ultrapure dialysate; water quality