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Clinical Trials/JPRN-jRCTs031200342
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

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.

Registry
who.int
Start Date
February 2, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Kawata Mitsuhiro

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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