Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery (ulistin)
The purpose of the present study is to determine whether ulinastatin, urinary anti-trypsin inhibitor, attenuates cardiopulmonary bypass (CPB)-activated systemic inflammatory response in cardiac surgery with CPB.
Serial measurements and analysis of several inflammatory cytokines (bactericidal permeability increasing protein, interleukin-6, tumor necrosis factor-α)as well as markers of cardiac injury, renal impairment and oxygenation profile will be performed to determine ulinastatin's efficacy.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Effect of Ulinastatin on Postoperative Systemic Inflammatory Response in Cardiac Surgery|
- bactericidal permeability increasing protein [ Time Frame: 5-30 min before the end of anesthesia ]
- interleukin-6 [ Time Frame: 5-30 min before the end of anesthesia ]
- tumor necrosis factorTNF-α [ Time Frame: 5-30 min before the end of anesthesia ]
- Creatine kinase-MB [ Time Frame: before anesthesia, 24 hour after the end of anesthesia ]
- troponin I [ Time Frame: before anesthesia, 24 hour after the end of anesthesia ]
- C-reactive protein [ Time Frame: before anesthesia, 24 hour after the end of anesthesia ]
- serum creatinine [ Time Frame: before anesthesia, 24 hour after the end of anesthesia ]
- PaO2/FiO2 ratio [ Time Frame: before anesthesia, 24 hour after the end of anesthesia ]
|Study Start Date:||March 2008|
|Study Completion Date:||August 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
normal saline, same amount, iv
placebo (the same amount of normal saline) iv before the initiation of CPB
Other Name: normall saline
Active Comparator: ulinastatin
5000 unit/kg iv
ulinastatin 5000 unit/kg iv before the initiation of CPB
Other Name: ulistin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518569
|Korea, Republic of|
|Konkuk University Medical Center|
|Seoul, Korea, Republic of, 143-729|