ulistin: Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: placebo normal saline, same amount, iv |
Drug: placebo
placebo (the same amount of normal saline) iv before the initiation of CPB
Other Names:
|
| Active Comparator: ulinastatin 5000 unit/kg iv |
Drug: ulinastatin
ulinastatin 5000 unit/kg iv before the initiation of CPB
Other Names:
|
Outcome Measures
Primary Outcome Measures
- bactericidal permeability increasing protein [5-30 min before the end of anesthesia]
- interleukin-6 [5-30 min before the end of anesthesia]
- tumor necrosis factorTNF-α [5-30 min before the end of anesthesia]
Secondary Outcome Measures
- Creatine kinase-MB [before anesthesia, 24 hour after the end of anesthesia]
- troponin I [before anesthesia, 24 hour after the end of anesthesia]
- C-reactive protein [before anesthesia, 24 hour after the end of anesthesia]
- serum creatinine [before anesthesia, 24 hour after the end of anesthesia]
- PaO2/FiO2 ratio [before anesthesia, 24 hour after the end of anesthesia]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Konkuk University Medical Center | Seoul | Korea, Republic of | 143-729 |
Sponsors and Collaborators
- Konkuk University Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Hill GE. Cardiopulmonary bypass-induced inflammation: is it important? J Cardiothorac Vasc Anesth. 1998 Apr;12(2 Suppl 1):21-5. Review.
- Nakanishi K, Takeda S, Sakamoto A, Kitamura A. Effects of ulinastatin treatment on the cardiopulmonary bypass-induced hemodynamic instability and pulmonary dysfunction. Crit Care Med. 2006 May;34(5):1351-7.
- KUH1160040