Konkuk University Medical Center
Seoul, 143-729, South Korea
NCT Number: NCT01518569
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.
Looking for future studies?
Notify Me25 year–75 year
All sexes
Interventional
Phase 4
Seoul, 143-729, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ulinastatin 5000 unit/kg iv before the initiation of CPB
Other names: ulistin
placebo (the same amount of normal saline) iv before the initiation of CPB
Other names: normall saline
Time frame: 5-30 min before the end of anesthesia
Time frame: 5-30 min before the end of anesthesia
Time frame: 5-30 min before the end of anesthesia
Time frame: before anesthesia, 24 hour after the end of anesthesia
Time frame: before anesthesia, 24 hour after the end of anesthesia
Time frame: before anesthesia, 24 hour after the end of anesthesia
Time frame: before anesthesia, 24 hour after the end of anesthesia
Time frame: before anesthesia, 24 hour after the end of anesthesia
Konkuk University Medical Center
Other
Effect of Ulinastatin on Postoperative Systemic Inflammatory Response in Cardiac Surgery
Acronym: ulistin
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07738250
Cancer Survivorship, Cardiovascular Disease
View Trial DetailsNCT01778569
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT02840448
Aortic Stenosis, Supravalvular, Aortic Valve Disease
Bethesda, Maryland, United States
View Trial DetailsNCT01934660
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial Details