It is reported that sivelstat improved and preserved the postoperative renal function in the orthopedic management. Moreover because sivelstat reduced the migration of neutrophil, it improved acute lung injury. During liver resection, Pringle maneuver, clamping the hepatoduodenal ligament, was performed. Pringle maneuver causes reperfusion injury of the liver. We have a hypothesis that sivelstat prevent the warm shock of reperfusion injury of the liver by Pringle maneuver.
Primary Outcome Measures:
- The incidence of liver damage due to reperfusion injury by Pringle maneuver was measured by several cytokines, including IL-8, IL-6, and HMGB-1. [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The duration of ICU stay and hospital stay, postoperative complications, and the liver damage at 6 POD, measuring hepato-biliary enzyme [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]
| Enrollment: |
50 |
| Study Start Date: |
April 2007 |
| Study Completion Date: |
July 2008 |
| Primary Completion Date: |
May 2008 (Final data collection date for primary outcome measure) |
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2: Active Comparator
250mL of 5% glucose plus 300mg of sivelstat was infected through the vein at 10mL per an hour
|
Drug: sivelstat
sivelstat sodiumhydrate
|
|
1: Placebo Comparator
250mL of 5% glucose was injected though the vein at 10mL per an hour
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Drug: glucose
glucose
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Whether the incidence of postoperative morbidities, such as liver failure, renal failure, or congestive heart failure, was reduced by administration of perioperative sivelstat.
Purpose
