{"id":30400,"date":"2026-05-21T04:03:00","date_gmt":"2026-05-20T20:03:00","guid":{"rendered":"https:\/\/csccm.org.cn\/?p=30400"},"modified":"2026-05-21T05:43:04","modified_gmt":"2026-05-20T21:43:04","slug":"30400","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=30400","title":{"rendered":"[JAMA Netw Open\u53d1\u8868\u8bba\u6587]\uff1a\u897f\u7ef4\u6765\u53f8\u94a0\u4e0e\u5fc3\u8840\u7ba1\u5916\u79d1\u672f\u540eARDS\u7684\u53d1\u75c5\u7387"},"content":{"rendered":"\n

Original Investigation <\/p>\n\n\n\n

Cardiology<\/p>\n\n\n\n

Sivelestat and Incidence of Acute Respiratory Distress Syndrome After Cardiovascular Surgery: A Randomized Clinical Trial<\/h1>\n\n\n\n

Tuo Pan, Can Xu, Ya-Peng Wang, et al<\/h3>\n\n\n\n

JAMA Netw Open 2026;9;(3):e260390.<\/h3>\n\n\n\n

doi:10.1001\/jamanetworkopen.2026.0390<\/h3>\n\n\n\n

Key Points<\/p>\n\n\n\n

Question<\/strong>  Does postoperative administration of the neutrophil elastase inhibitor sivelestat reduce the incidence of acute respiratory distress syndrome (ARDS) among patients undergoing cardiovascular surgery with cardiopulmonary bypass?<\/p>\n\n\n\n

Findings<\/strong>  In this randomized, placebo-controlled clinical trial of 424 patients, sivelestat significantly reduced the incidence of postoperative ARDS (16.8% vs 31.2%) and 90-day all-cause mortality (1.1% vs 5.2%) compared with placebo.<\/p>\n\n\n\n

Meaning<\/strong>  These findings suggest that sivelestat may be an effective pharmacologic strategy for preventing ARDS and improving survival in patients undergoing cardiovascular surgery with cardiopulmonary bypass.<\/a><\/p>\n\n\n\n

Abstract<\/p>\n\n\n\n

Importance<\/strong>  Acute respiratory distress syndrome (ARDS) represents a frequent and serious complication after cardiovascular surgery. Although sivelestat, a specific neutrophil elastase inhibitor, has demonstrated therapeutic potential in preliminary studies, the evidence remains limited by methodological constraints of observational designs and underpowered studies.<\/p>\n\n\n\n

Objective<\/strong>  To evaluate the efficacy of sivelestat vs placebo in reducing the incidence of postoperative ARDS and associated complications among patients undergoing major cardiovascular procedures.<\/p>\n\n\n\n

Design, Setting, and Participants<\/strong>  This single-center, randomized, placebo-controlled clinical trial conducted at a tertiary care academic medical center om China enrolled 424 participants between February 15, 2024, and April 16, 2025, with a 90-day postoperative follow-up period. Participants were consecutive patients scheduled for cardiovascular surgery, including coronary artery bypass grafting, valve surgeries, ascending aortic reconstruction, combined procedures, congenital heart defect repairs, and cardiac tumor resections.<\/p>\n\n\n\n

Interventions<\/strong>  Participants were randomly allocated (1:1) to receive either continuous intravenous sivelestat (0.2 mg\/kg\/h), initiated immediately on intensive care unit (ICU) admission postoperatively and continued for up to 7 days or until ICU discharge; or volume-matched 0.9% sodium chloride placebo administered on an identical schedule.<\/p>\n\n\n\n

Main Outcomes and Measures<\/strong>  The primary outcome was the incidence of ARDS. Secondary outcomes included serial measurements of inflammatory biomarkers, including interleukin 6 and interleukin 8, tumor necrosis factor, systemic immune-inflammation index, and serum neutrophil elastase, on postoperative days 1, 3, 5, and 7, along with ARDS-related clinical outcomes including death, pneumonia, and reintubation. Analysis was performed on an intention-to-treat basis.<\/p>\n\n\n\n

Results<\/strong>\u00a0\u00a0Among 424 randomized patients, 382 completed the trial (mean [SD] age, 62.9 [6.2] years; 210 male [55.0%]). Adverse events monitored for safety did not differ between groups. The sivelestat group had significantly lower rates of ARDS (16.8% [32 of 190] vs 31.2% [60 of 192];\u00a0P<\/em>\u2009<\u2009.001), and 90-day mortality (1.1% [2 of 190] vs 5.2% [10 of 192];\u00a0P<\/em>\u2009=\u2009.02). Postoperative inflammatory biomarkers, including neutrophil elastase and interleukin 6, were significantly reduced in the sivelestat group.<\/p>\n\n\n\n

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Conclusion and Relevance<\/strong>  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. Sivelestat attenuated neutrophil-driven inflammation by dynamically suppressing neutrophil elastase and reducing key downstream biomarkers. These preliminary findings suggest sivelestat may be a pharmacologic option to mitigate ARDS in cardiovascular procedures.<\/p>\n\n\n\n

Trial Registration<\/strong>  ClinicalTrials.gov Identifier: NCT06276569<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Original Investigation  Cardiology Sivelestat and […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/30400"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=30400"}],"version-history":[{"count":3,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/30400\/revisions"}],"predecessor-version":[{"id":30770,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/30400\/revisions\/30770"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=30400"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=30400"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=30400"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}