Cardiothoracic & vascular anesthesia

Sivelestat and Incidence of Acute Respiratory Distress Syndrome After Cardiovascular Surgery: A Randomized Clinical Trial

JAMA Netw OpenPublished Randomised controlled trial

Authors' conclusion

In this single-center, randomized, placebo-controlled clinical trial of patients undergoing cardiovascular surgery, sivelestat significantly reduced ARDS incidence and 90-day all-cause mortality.

Study context

Population
Consecutive patients scheduled for cardiovascular surgery at a tertiary academic centre in China382 completed
Participants
424 patients
Comparison
Sivelestat vs placebo
  • Sivelestatn = 190
  • Placebon = 192reference
Primary endpoint
Incidence of acute respiratory distress syndrome (ARDS)
Methodological detailssingle-centre, placebo-controlled
  • Single-centre
  • Placebo-controlled

Primary result

As reported in the abstract

ARDS

P < 0.001

Secondary outcomes

90-day mortality

P = 0.02

Postoperative inflammatory biomarkers (neutrophil elastase, interleukin 6)

Significantly reduced in the sivelestat group

Safety

Adverse events

Did not differ between groups

Original publication

Sivelestat and Incidence of Acute Respiratory Distress Syndrome After Cardiovascular Surgery: A Randomized Clinical Trial. JAMA Netw Open. Published 2 March 2026. doi:10.1001/jamanetworkopen.2026.0390

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