Possible clinical effects of molecular hydrogen (H2) delivery during hemodialysis in chronic dialysis patients: Interim analysis in a 12 month observation

Abstract

Background and aim: It is supposed that enhanced oxidative stress and inflammation are involved with the poor clinical outcomes in patients on chronic dialysis treatment. Recent studies have shown that molecular hydrogen (H2) is biologically active as an anti-inflammatory agent. Thus, we developed a novel hemodialysis (E-HD) system which delivers H2 (30 to 80 ppb)-enriched dialysis solution, to conduct a prospective observational study (UMIN000004857) in order to compare the long-term outcomes between E-HD and conventional-HD (C-HD) in Japan. The present interim analysis aimed to look at potential clinical effects of E-HD during the first 12 months observation. Subjects and method: 262 patients (140, E-HD; 122, C-HD) were subjected for analysis for comprehensive clinical pro- files. They were all participating in the above mentioned study, and they had been under the respective HD treatment for 12 consecutive months without hospitalization. Collected data, such as, physical and laboratory examinations, medications, and self-assessment questionnaires on subjective symptoms (i.e., fatigue and pruritus) were compared between the two groups. Results: In a 12-month period, no clinical relevant differences were found in dialysis-related parameters between the two groups. However, there were differences in the defined daily dose of anti-hypertensive agents, and subjective symptoms, such as severe fatigue, and pruritus, which were all less in the E-HD group. Multivariate analysis revealed E-HD was an independent significant factor for the reduced use of anti-hypertensive agents as well as the absence of severe fatigue and pruritus at 12 months after adjusting for confounding factors. Conclusion The data indicates E-HD could have substantial clinical benefits beyond conventional HD therapy, and support the rationale to conduct clinical trials of H2 application to HD treatment.

Study details

Article type

Original Research

Disease / injury model

Chronic kidney disease (end-stage renal disease) on hemodialysis

Duration

12 months

Dose comparison

The study used a single range of hydrogen concentration (30-80 ppb) in the E-HD group; no dose/concentration comparison was performed.

Dose-dependent effect

No

Outcome

Positive

Findings

Electrolyzed water hemodialysis (E-HD) delivering molecular hydrogen-enriched dialysate reduced the required dose of anti-hypertensive agents and ameliorated symptoms such as fatigue and pruritus in chronic dialysis patients compared to conventional hemodialysis (C-HD), with no clinically relevant differences in other dialysis-related parameters.