NCT00738348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

Enrollment Period

1.1 years

First QC Date

August 18, 2008

Last Update Submit

June 6, 2012

Conditions

Liver Diseases

Keywords

surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • The duration of ICU stay and hospital stay, postoperative complications, and the liver damage at 6 POD, measuring hepato-biliary enzyme

    during hospitalization

Study Arms (2)

2

ACTIVE COMPARATOR

250mL of 5% glucose plus 300mg of sivelstat was infected through the vein at 10mL per an hour

Drug: sivelstat

1

PLACEBO COMPARATOR

250mL of 5% glucose was injected though the vein at 10mL per an hour

Drug: glucose

Interventions

sivelstatDRUG

sivelstat sodiumhydrate

Also known as: sivelstat sodiumhydrate, ONO PHARMACEUTICAL CO
2
glucoseDRUG

glucose

1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • liver disease which surgical management was indicated

You may not qualify if:

  • weight loss greater than 10 per cent during the previous 6 months, signs of distant metastasis, or of respiratory, renal or heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kochi Medical School

Kohasu-Okocho, Nankoku, 783-8505, Japan

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Glucose

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Takehiro Okabayashi, MD, PhD

    Kochi Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

April 1, 2007

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

June 8, 2012

Record last verified: 2012-06

Locations

JP(1)