Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | August 18, 2008 | ||||
Last Updated Date | August 19, 2008 | ||||
Start Date † | April 2007 | ||||
Current 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 ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00738348 on ClinicalTrials.gov Archive Site | ||||
Current 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 ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Effect of Perioperative Sivelstat Administration for Liver Resection | ||||
Official Title † | Effect of Perioperative Sivelstat Administration for Liver Resection | ||||
Brief Summary | 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. |
||||
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. |
||||
Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Liver Diseases | ||||
Intervention † |
|
||||
Study Arms / Comparison Groups |
|
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 50 | ||||
Completion Date | July 2008 | ||||
Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | Japan | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00738348 | ||||
Responsible Party | Kochi Medical School, Kochi University | ||||
Secondary IDs †† | Kochi University | ||||
Study Sponsor † | Kochi University | ||||
Collaborators †† | |||||
Investigators † |
|
||||
Information Provided By | Kochi University | ||||
Verification Date | August 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |