Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery (ulistin)

Konkuk University Medical Center

Status and phase: Completed; Phase 4

Conditions: Cardiovascular Disease

Treatments: Drug: ulinastatin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01518569

KUH1160040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

normal saline, same amount, iv

Treatment:

Drug: placebo

ulinastatin

Active Comparator group

Description:

5000 unit/kg iv

Treatment:

Drug: ulinastatin