Effect of Ulinastatin on Postoperative Systemic Inflammatory Response in Cardiac Surgery
Applying aortic cross-clamp (ACC) and cardiopulmonary bypass (CPB) for cardiac surgery
produces variable systemic inflammatory reactions. As a common complication of those
reactions, pulmonary dysfunction, which usually indicated by postoperative hypoxemia, is
frequently associated with cardiac surgery employing CPB and has been used as a major
predictor of morbidity and mortality.
Circulating humoral and cellular factors are involved in the development of the systemic
inflammatory reactions including organ dysfunction. So far, many studies analyzed the
concentration of inflammatory marker (cytokine) to determine the degree of systemic
inflammatory responses in various conditions.
Ulinastatin has anti-inflammatory activity and suppresses the infiltration of neutrophils.
Previous studies suggested ulinastatin's cytoprotective effect against ischemia-reperfusion
injury in major organs and its inhibition of inflammatory marker production.
The purpose of the present study is to determine ulinastatin's possible protective efficacy
of in attenuating CPB-activated systemic inflammatory response regarding postoperative
cardiac, renal and pulmonary dysfunction in cardiac surgery with CPB. Serial measurements
and analysis of several inflammatory cytokines, such as bactericidal permeability increasing
protein (BPI), interleukin (IL)-6, tumor necrosis factor (TNF)-α, as well as markers of
cardiac injury, renal impairment and oxygenation profile, such as creatine kinase-MB
(CK-MB), troponin I (TnI), C-reactive protein (CRP), arterial O2 tension /inspired O2
fraction (PaO2/FiO2 ratio), will be performed to this purpose.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
bactericidal permeability increasing protein
5-30 min before the end of anesthesia
Korea: Food and Drug Administration