Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery (ulistin)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease |
Drug: ulinastatin Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study 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 ] [ Designated as safety issue: No ]
- interleukin-6 [ Time Frame: 5-30 min before the end of anesthesia ] [ Designated as safety issue: No ]
- tumor necrosis factorTNF-α [ Time Frame: 5-30 min before the end of anesthesia ] [ Designated as safety issue: No ]
- Creatine kinase-MB [ Time Frame: before anesthesia, 24 hour after the end of anesthesia ] [ Designated as safety issue: No ]
- troponin I [ Time Frame: before anesthesia, 24 hour after the end of anesthesia ] [ Designated as safety issue: No ]
- C-reactive protein [ Time Frame: before anesthesia, 24 hour after the end of anesthesia ] [ Designated as safety issue: No ]
- serum creatinine [ Time Frame: before anesthesia, 24 hour after the end of anesthesia ] [ Designated as safety issue: No ]
- PaO2/FiO2 ratio [ Time Frame: before anesthesia, 24 hour after the end of anesthesia ] [ Designated as safety issue: No ]
| Enrollment: | 26 |
| Study Start Date: | March 2008 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: placebo
normal saline, same amount, iv
|
Drug: placebo
placebo (the same amount of normal saline) iv before the initiation of CPB
Other Name: normall saline
|
|
Active Comparator: ulinastatin
5000 unit/kg iv
|
Drug: ulinastatin
ulinastatin 5000 unit/kg iv before the initiation of CPB
Other Name: ulistin
|
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.
Eligibility| Ages Eligible for Study: | 25 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
Publications:
| Responsible Party: | Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01518569 History of Changes |
| Other Study ID Numbers: | KUH1160040 |
| Study First Received: | January 20, 2012 |
| Last Updated: | January 25, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Konkuk University Medical Center:
|
ulinastatin systemic inflammation cardiac surgery cardiopulmonary bypass |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Inflammation Pathologic Processes Urinastatin Trypsin Inhibitors |
Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013