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

China30 participantsStarted 2023-05

Plain-language 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).

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Aged 18-75;
✓. Spontaneous acute (≤14 days) type A aortic dissection;
✓. In the emergency department, hypothermic circulatory arrest combined with unilateral anterograde cerebral perfusion was expected to be performed on the aortic arch surgery;
✓. Preoperative PaO2/FiO2≤200mmHg;

Exclusion criteria

✕. Preoperative cardiogenic shock;
✕. preoperative liver insufficiency;
✕. Preoperative dissection involves important organs and seriously endangers the patient's life
✕. Pregnant women;
✕. hereditary connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome, etc.;
✕. Behcet's disease;
✕. aortitis;
✕. There is a history of neurologic disease that has been clearly diagnosed;

What they're measuring

Invasive mechanical ventilation time

Timeframe: 28 days after surgery

Trial details

NCT IDNCT05874700

SponsorXiaotong Hou

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Xiaotong Hou, MD

8610 64456631 xt.hou@ccmu.edu.cn

View on ClinicalTrials.gov More Acute Aortic Dissection trials