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) studied | Chronic kidney disease G5D (under hemodialysis) |
| Date of first enrollment | 07/03/2025 |
| Target sample size | 10 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Hydrogen inhalation (250 mL/min) for 24 weeks during haemodialysis (3 times a week for approx. 4 hr/treatment). |
Outcome(s)
| Primary Outcome | Safety (adverse events) |
|---|---|
| Secondary Outcome | Relationship 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 maximum | Not applicable |
| Gender | Both |
| 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
| Primary Sponsor | Shibuya Masaki |
|---|---|
| Secondary Sponsor | Sano Motoaki |
| Source(s) of Monetary Support | Doctors Man Co. Ltd. |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Masaki Shibuya |
| Address | 1-1-1, Minamikogushi, Ube-shi, Yamaguchi-ken Yamaguchi Japan 755-8505 |
| Telephone | +81-836-22-2248 |
| 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 |
| mshibuya@yamaguchi-u.ac.jp | |
| Affiliation | Yamaguchi University Hospital |