Effect of Perioperative Sivelstat Administration for Liver Resection (KMS)
This study has been completed.
Sponsor:
Kochi University
Information provided by (Responsible Party):
Takehiro Okabayashi, Kochi University
ClinicalTrials.gov Identifier:
NCT00738348
First received: August 18, 2008
Last updated: June 6, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Liver Diseases |
Drug: sivelstat Drug: glucose |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Effect of Perioperative Sivelstat Administration for Liver Resection |
Resource links provided by NLM:
MedlinePlus related topics:
Liver Diseases
Drug Information available for:
Dextrose
U.S. FDA Resources
Further study details as provided by Kochi University:
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) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 2
250mL of 5% glucose plus 300mg of sivelstat was infected through the vein at 10mL per an hour
|
Drug: sivelstat
sivelstat sodiumhydrate
Other Name: sivelstat sodiumhydrate, ONO PHARMACEUTICAL CO
|
|
Placebo Comparator: 1
250mL of 5% glucose was injected though the vein at 10mL per an hour
|
Drug: glucose
glucose
Other Name: glucose
|
Detailed Description:
Whether the incidence of postoperative morbidities, such as liver failure, renal failure, or congestive heart failure, was reduced by administration of perioperative sivelstat.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- liver disease which surgical management was indicated
Exclusion Criteria:
- weight loss greater than 10 per cent during the previous 6 months, signs of distant metastasis, or of respiratory, renal or heart disease
Contacts and Locations More Information
No publications provided
| Responsible Party: | Takehiro Okabayashi, University, Kochi University |
| ClinicalTrials.gov Identifier: | NCT00738348 History of Changes |
| Other Study ID Numbers: | ESAR, Kochi University |
| Study First Received: | August 18, 2008 |
| Last Updated: | June 6, 2012 |
| Health Authority: | Japan: Ministry of Education, Culture, Sports, Science and Technology |
Keywords provided by Kochi University:
|
surgery |
Additional relevant MeSH terms:
|
Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013