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Safety study of hydrogen gas inhalation for pulmonary oxygenation disorders in patients with acute aortic dissection Stanford type B

Safety study of hydrogen gas inhalation for pulmonary oxygenation disorders in patients with acute aortic dissection Stanford type B

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031200342
Enrollment
10
Registered
2021-02-02
Start date
2022-02-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute aortic dissection Acute aortic dissection

Interventions

Inhale a mixed gas of oxygen and hydrogen for 8 hours a day for 3 days

Sponsors

Kawata Mitsuhiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 40 years or older at the time of consent 2. Patients diagnosed with Stanford type B due to acute aortic dissection 3. Patients who can perform hydrogen gas inhalation therapy within 24 hours after entering the intensive care unit 4. Patients who understand the content of this study and can obtain written consent from the patient

Exclusion criteria

Exclusion criteria: 1. Patients with traumatic aortic dissection 2. Patients with rupture due to acute aortic dissection or scheduled for emergency surgery including stent graft 3. Patients suspected of having a bacterial infection, such as elevated procalcitonin levels before the start of hydrogen gas inhalation therapy 4.Patients clinically suspected of having a fungal infection before the onset of acute aortic dissection. (Whether or not there is a suspicion of a fungal infection will be determined by the attending physician based on clinical symptoms before the start of hydrogen inhalation. In addition, based on the results of beta-D-glucan before the start, cases with strong suspicion of fungal infection should be discontinued immediately after diagnosis.) 5. Patients with severe liver dysfunction equivalent to Grade C in the Child-Pugh classification 6. Patients with renal dysfunction requiring dialysis 7. Patients taking immunosuppressive drugs 8. Patients who have started or will start ventilator or ECMO 9. Patients with or suspected of having lung disorders (pneumonitis, COPD) 10.Patients with poor respiratory function who require 50 percent or more FiO2 to maintain PaO2. (Reservoir mask 15 L per min with FiO2 50 percent, PaO2 less than 60 mmHg) 11. Patients with or suspected of having cancer 12. Other patients who the investigator has determined to be ineligible for this study

Design outcomes

Primary

MeasureTime frame
Incidence of related adverse events from the start of hydrogen administration to 4 days

Secondary

MeasureTime frame
AaDO2, PaO2, PaCO2, respiratory rate, P / F ratio, CRP, WBC value, body temperature, oxygen therapy required period

Contacts

Public ContactMami Yoshioka

Tokyo Metropolitan Geriatric Medical Center

mami_yoshioka@tmghig.jp+81-3-3964-1141

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026