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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

Kawata Mitsuhiro

Tokyo Metropolitan Geriatric Medical Center

35-2 Sakaecho, Itabashi-ku, Tokyo

mitsuhiro_kawata@tmghig.jp

Yoshioka Mami

Tokyo Metropolitan Geriatric Medical Center

35-2 Sakaecho, Itabashi-ku, Tokyo

+81-3-3964-1141

mami_yoshioka@tmghig.jp

Not Recruiting

Feb. 02, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

prevention purpose

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

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

Both

Acute aortic dissection

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

Acute aortic dissection

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

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

+81-3-3964-1141

Jan. 26, 2021

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