Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Lung Injury or Acute Respiratory Distress Syndrome After Cardiac Surgery

Summary

The aim of this study is to assess the effectiveness and safety of sivelestat sodium in preventing acute lung injury and/or acute respiratory distress syndrome (ALI/ARDS) following cardiac surgery, with the objective of providing evidence-based support for its clinical application.

Timeline

Start

2024-02-18

Primary completion

2025-04-30

Completion

2025-07-30

Outcome

Met primary endpoint

paper The sivelestat group had significantly lower rates of ARDS (16.8% [32 of 190] vs 31.2% [60 of 192]; P < .001) PMID 41811317 ↗

Publications

• Pan T, Xu C, Wang YP, Wang HL, Su WX, Zhang HT, Zhu EJ, Li YT, Lv ZK, Zhu TT, Xu ZW, Gao Y, Xu CZ, Shi J, Ji WJ, Duan ZH, Zhang C, Xu ZJ, Li KS, Chong H, Zhu XY, Xue YX, Xu WZ, Chen C, Zhao WW, Ye JX, Ge M, Xu GJ, Wu SM, Pan J, Wang DJ, Qu JZ, Wang Q. Sivelestat and Incidence of Acute Respiratory Distress Syndrome After Cardiovascular Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e260390. doi: 10.1001/jamanetworkopen.2026.0390.

Drugs

Indications