Original Investigation

Sivelestat and Incidence of Acute Respiratory Distress Syndrome After Cardiovascular Surgery

JAMA Network Open 10.1001/jamanetworkopen.2026.0390

March 11, 2026 at 11:00 AM EDT

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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?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.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.

Corresponding Authors: Qiang Wang, MD, Cardiovascular Medical Center, Nanjing Drum Tower Hospital, Building 21, No. 99, Qunli Avenue, Economic Development Zone, Nanjing, Jiangsu, 210000, China (njuwangqiang@163.com); Jason Z. Qu, MD, Division of Cardiac Anesthesia, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, 55 Fruit St, Jackson 4-418, Boston, MA 02114 (jqu@mgh.harvard.edu).

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