Novel haemodialysis (HD) treatment employing molecular hydrogen (H2)-enriched dialysis solution improves prognosis of chronic dialysis patients: A prospective observational study
Masaaki Nakayama, Noritomo Itami, Hodaka Suzuki, Hiromi Hamada, Ryo Yamamoto, Kazumasa Tsunoda, Naoyuki Osaka, Hirofumi Nakano, Yukio Maruyama, Shigeru Kabayama, Ryoichi Nakazawa, Mariko Miyazaki, Sadayoshi Ito
Scientific Reports · 2018 · 8(1) · 254
Abstract
Recent studies have revealed unique biological characteristics of molecular hydrogen (H2) as an anti-inflammatory agent. We developed a novel haemodialysis (E-HD) system delivering an H2 (30–80 ppb)-enriched dialysis solution by water electrolysis, and conducted a non-randomized, non-blinded, prospective observational study exploring its clinical impact. Prevalent chronic HD patients were allocated to either the E-HD (n = 161) group or the conventional HD (C-HD: n = 148) group, and received the respective HD treatments during the study. The primary endpoint was a composite of all-cause mortality and development of non-lethal cardio-cerebrovascular events (cardiac disease, apoplexy, and leg amputation due to peripheral artery disease). During the 3.28-year mean observation period, there were no differences in dialysis parameters between the two groups; however, post-dialysis hypertension was ameliorated with significant reductions in antihypertensive agents in the E-HD patients. There were 91 events (50 in the C-HD group and 41 in the E-HD group). Multivariate analysis of the Cox proportional hazards model revealed E-HD as an independent significant factor for the primary endpoint (hazard ratio 0.59; [95% confidence interval: 0.38–0.92]) after adjusting for confounding factors (age, cardiovascular disease history, serum albumin, and C-reactive protein). HD applying an H2-dissolved HD solution could improve the prognosis of chronic HD patients.
Study details
- Article type
- Original Research
- Disease / injury model
- Chronic kidney disease (end-stage renal disease) in haemodialysis patients
- Duration
- 3 years
- Dose comparison
- No direct dose/concentration comparison within the E-HD group; all patients received 30–80 ppb H2.
- Outcome
- Positive
- Findings
- During the 3.28-year mean observation period, there were no differences in dialysis parameters between the two groups. However, post-dialysis hypertension was ameliorated with significant reductions in antihypertensive agents in the E-HD patients. Additionally, haemodialysis using H2-enriched dialysis solution (E-HD) significantly reduced the risk of all-cause mortality and non-lethal cardio-cerebrovascular events compared to conventional HD, with improved post-dialysis hypertension and reduced need for antihypertensive agents, and no observed adverse effects.
Classification
- Study Type
- Study Design
- Species
- Physiological Systems
- Biomarkers
- Methods of Administration
- Countries
- Also
- Drug/Therapy/Supplement ComparedPharmacokinetics DiscussedERW DiscussedH2 Safety Discussed
