Cardiopulmonary bypass (CPB) evokes activation of a systemic inflammatory response.
Sivelestat has been used clinically to treat
acute lung injury associated with
systemic inflammatory response syndrome. This prospective, doubleblind, randomized study was designed to evaluate the effects of
sivelestat in the
perioperative period of elective pediatric open-heart surgery with CPB. Twenty-six consecutive pediatric patients weighing between 5 and 10 kg and undergoing open-heart surgery with CPB were divided into a
sivelestat group (n = 13) and a control group (n = 13). The patients in the
sivelestat group were administered a continuous
intravenous infusion of 0.2 mg/kg/hour of
sivelestat, and the patients in the control group were administered the same volume of
0.9% saline from the initiation of CPB to 24 hours after surgery. Blood samples were drawn for the measurement of
cytokines, polymorphonuclear
elastase (PMN-E), white blood cell count (WBC), neutrophil count (NC), and
C-reactive protein (CRP). There were no significant differences in
cytokine data between the two groups. The peak PMN-E and WBC levels were significantly increased in the control group (P = 0.049, P = 0.039). The WBC and NC levels immediately after surgery in the control group were significantly greater than those in the
sivelestat group (P = 0.049, P = 0.044). The peak CRP level in the control group was significantly greater than the
sivelestat group (P = 0.04), and the CRP level on postoperative day 4 in the control group was significantly greater than in the
sivelestat group (P = 0.014). This study showed that
sivelestat attenuates the perioperative inflammatory response in pediatric heart surgery with CPB.