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A pilot randomized study of the neutrophil elastase inhibitor, Sivelestat, in patients undergoing cardiac surgery

^a Department of Cardiovascular Surgery, Social Insurance Chukyo Hospital, 1-1-10 Sanjyo, Minami-ku, Nagoya, 457-8510, Japan
^b Department of Cardiovascular Surgery, Graduate School of Medicine, Nagoya University, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
^c Department of Cardiovascular Surgery, Kanazawa Medical University, 1-1, Daigaku, Uchinada-cho, Kawakita-gun, Ishikawa, 920-0293, Japan

*Corresponding author. Tel.: +81-52-691-7151; fax: +81-52-692-5220.

E-mail address: tomonobuabe{at}hotmail.com (T. Abe).

The primary objective of this study was to determine the feasibility and safety of treatment with Sivelestat in humans to attenuate post-cardiopulmonary bypass lung injury. Twenty patients scheduled to undergo on-pump coronary artery bypass surgery were randomized to receive either 0.3 mg/kg/h intravenous Sivelestat sodium (Sivelestat group; n=10) or isotonic sodium chloride solution (placebo group, n=10), peri-operatively. Postoperative adverse events were recorded until hospital discharge. The alveolar–arterial oxygen gradient (A-aDO₂), intrapulmonary shunt (Qs/Qt) and dynamic lung compliance were determined four times peri-operatively as secondary exploratory outcomes. All patients completed study protocol without discontinuation of intervention. The number of total adverse clinical outcomes, including atrial fibrillation and superficial wound infection, was nine in seven patients in the placebo group and four in four patients in the Sivelestat group (P=0.37). The mean duration of the postoperative hospital stay was shorter in the Sivelestat group (19.0±3.4 vs. 25.6±9.1, P=0.04). The exploratory analysis of relative changes in lung functions showed trends toward attenuation of lung injury in the Sivelestat group in all three pulmonary parameters, though the inter-group difference could be due to chance (P>0.05). It is feasible to administer Sivelestat as a preventive measure against lung dysfunction after cardiopulmonary bypass.

Key Words: Cardiopulmonary bypass; Inflammatory response; Coronary artery bypass grafts; Pulmonary function; Peri-operative care