Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Konkuk University Medical Center
• Treatments: Urinastatin

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