A Phase 4 interventional study of ulinastatin and placebo in Cardiovascular Disease, sponsored by Konkuk University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-01-26.
Sponsored by Konkuk University Medical Center · Phase 4, Interventional, and Prevention
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 26 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Konkuk University Medical Center is the lead sponsor of 93 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
normal saline, same amount, iv
Drug: placebo
5000 unit/kg iv
Drug: ulinastatin
ulinastatin 5000 unit/kg iv before the initiation of CPB
Also known as: ulistin
placebo (the same amount of normal saline) iv before the initiation of CPB
Also known as: normall saline
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
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Konkuk University Medical Center