drugset / Trial / NCT01518569

Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery

NCT01518569

Phase 4 Completed 26 enrolled Konkuk University Medical Center
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2008-03
Primary completion
2008-06
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ulinastatin Protein / enzyme biologic 5000 iu/kg Intravenous