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Effect of Ulinastatin on Postoperative Systemic Inflammatory Response in Cardiac Surgery

Phase 4
25 Years
75 Years
Not Enrolling
Cardiovascular Disease

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Trial Information

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.

Inclusion Criteria:

- elective cardiac surgery employing CPB

Exclusion Criteria:

- urgent/emergency surgery,

- previous heart surgery,

- combined CABG and valve surgery,

- age > 75 yrs,

- left ventricular ejection fraction < 0.45,

- diabetes treated with insulin,

- active gastropathic disorder,

- treatment for chronic obstructive pulmonary disease,

- preoperative use of steroids

- postoperative re-operation due to bleeding control

- pre and postoperative renal replacement therapy

- left ventricular assist device implantation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

bactericidal permeability increasing protein

Outcome Time Frame:

5-30 min before the end of anesthesia

Safety Issue:



Korea: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

August 2008

Related Keywords:

  • Cardiovascular Disease
  • ulinastatin
  • systemic inflammation
  • cardiac surgery
  • cardiopulmonary bypass
  • Cardiovascular Diseases
  • Inflammation