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JRCT ID: jRCTs061240132

Registered date:07/03/2025

Study on the safety of hydrogen inhalation in hemodialysis patients.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedChronic kidney disease G5D (under hemodialysis)
Date of first enrollment07/03/2025
Target sample size10
Countries of recruitment
Study typeInterventional
Intervention(s)Hydrogen inhalation (250 mL/min) for 24 weeks during haemodialysis (3 times a week for approx. 4 hr/treatment).

Outcome(s)

Primary OutcomeSafety (adverse events)
Secondary OutcomeRelationship between hydrogen dosage and hydrogen blood concentration, expiratory gas analysis and ABI/CAVI, effect on anemia, effect on fatigue

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria(1) Patients who have been on maintenance haemodialysis (including haemodialysis and haemodiafiltration) for at least 3 months. (2) Patients who are at least 18 years of age at the time of consent . (3) Gender Not applicable. (4) Inpatient or outpatient Not applicable. (5) Patients who have been fully informed of the study and have given their voluntary written consent based on full understanding.
Exclude criteria(1) Patients with a history of or complicated with malignant tumours. However, patients with a history of malignant tumours who are untreated and have not relapsed for more than 5 years at the time of obtaining consent may be included. (2) Patients complicated with unstable angina or non-compensated heart failure. (3) Patients complicated with cirrhosis or liver failure. (4) Patients who require oxygen inhalation during dialysis. (5) Patients with frequent hypotension during dialysis (6)Patients who are judged to be inappropriate as research subjects by the principal investigator (co-principal investigator).

Related Information

Contact

Public contact
Name Masaki Shibuya
Address 1-1-1, Minamikogushi, Ube-shi, Yamaguchi-ken Yamaguchi Japan 755-8505
Telephone +81-836-22-2248
E-mail mshibuya@yamaguchi-u.ac.jp
Affiliation Yamaguchi University Hospital
Scientific contact
Name Masaki Shibuya
Address 1-1-1, Minamikogushi, Ube-shi, Yamaguchi-ken Yamaguchi Japan 755-8505
Telephone +81-836-22-2248
E-mail mshibuya@yamaguchi-u.ac.jp
Affiliation Yamaguchi University Hospital