Study of Sivelestat to Protect Lung and Organ Function After Cardiovascular Surgery in Adults with Aortic Dissection

What this Trial Is About

Systemic inflammatory response syndrome SIRS and multiple organ dysfunction syndrome MODS are major causes of death in patients with cardiovascular diseases. This research aims to evaluate whether immunomodulatory therapy with sivelestat during the acute phase of cardiovascular diseases can reduce the incidence of SIRS and MODS. The study focuses on patients diagnosed with thoracic aortic disease and type A acute aortic syndrome who are planning emergency surgery. Participants will be randomly assigned to one of two groups the experimental group receiving sivelestat and the control group receiving standard treatment without additional intervention. The sivelestat is given as a 24-hour intravenous infusion at a total dose of 4.8mgkg dissolved in saline, delivered at a steady rate using a microinfusion pump. The control group receives only the usual care without sivelestat. During the study, researchers will monitor participants for seven days after surgery, measuring the highest Sequential Organ Failure Assessment SOFA score to assess organ function. Additional monitoring includes tracking all-cause mortality within 30 days after surgery. Participants will undergo regular evaluations to assess lung function and organ status as part of the safety and effectiveness assessments throughout the study duration.

Protective Effect of Sivelestat Against Negative Pulmonary Function and Organ Dysfunction After Cardiovascular Surgery (PANDA VI)