A Pilot Study of Sivelestat Sodium to Shorten Mechanical Ventilation in Acute Aortic Dissection

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is A prospective, randomized, placebo-controlled, reestimable adaptive clinical study to evaluate the efficacy and safety of perioperative application of sivelestat sodium to shorten the duration of postoperative invasive mechanical ventilation in acute type A aortic dissection patients with preoperative moderate and severe hypoxemia (PaO2/FiO2≤200mmHg).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiaotong Hou
• Treatments: Glycine; Sivelestat

Criteria

Inclusion Criteria:

1. Aged 18-75;

2. Spontaneous acute (≤14 days) type A aortic dissection;

3. In the emergency department, hypothermic circulatory arrest combined with unilateral anterograde cerebral perfusion was expected to be performed on the aortic arch surgery;

4. Preoperative PaO2/FiO2≤200mmHg;

Exclusion Criteria:

1. Preoperative cardiogenic shock;

2. preoperative liver insufficiency;

3. Preoperative dissection involves important organs and seriously endangers the patient's life

4. Pregnant women;

5. hereditary connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome, etc.;

6. Behcet's disease;

7. aortitis;

8. There is a history of neurologic disease that has been clearly diagnosed;

9. There is a history of a clearly diagnosed mental illness;

10. There is a definite diagnosis of chronic respiratory disease;

11. There is a clearly diagnosed immune disease;

12. There is a definite diagnosis of hematological diseases;

13. severe renal failure or require dialysis treatment;

14. Taking anti-inflammatory or anti-coagulant drugs within a week before admission;

15. People who are allergic to sivelestat sodium and other ingredients;

16. Has participated in other clinical trials;

17. The clinician judges that it is not suitable for inclusion in the study;