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| ID | Type | Description | Link |
|---|---|---|---|
| Kochi University |
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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.
Whether the incidence of postoperative morbidities, such as liver failure, renal failure, or congestive heart failure, was reduced by administration of perioperative sivelstat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | 250mL of 5% glucose plus 300mg of sivelstat was infected through the vein at 10mL per an hour |
|
| 1 | Placebo Comparator | 250mL of 5% glucose was injected though the vein at 10mL per an hour |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sivelstat | Drug | sivelstat sodiumhydrate |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | during hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of ICU stay and hospital stay, postoperative complications, and the liver damage at 6 POD, measuring hepato-biliary enzyme | during hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takehiro Okabayashi, MD, PhD | Kochi Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kochi Medical School | Kohasu-Okocho, Nankoku | 783-8505 | Japan |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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| glucose | Drug | glucose |
|