JPRN-jRCTs031200342
Recruiting
Phase 1
Safety study of hydrogen gas inhalation for pulmonary oxygenation disorders in patients with acute aortic dissection Stanford type B
Kawata Mitsuhiro0 sites10 target enrollmentFebruary 2, 2021
ConditionsAcute aortic dissection
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute aortic dissection
- Sponsor
- Kawata Mitsuhiro
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
Outcomes
Primary Outcomes
Not specified
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