Back to resultsEffect of an Artificial Pancreas in Patients Undergoing Hepatic Resection
Primary Purpose
Liver Diseases
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
Sponsored by
About this trial
This is an interventional prevention trial for Liver Diseases focused on measuring surgical, site, infection
Eligibility Criteria
Inclusion Criteria:
- This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system.
Exclusion Criteria:
- weight loss greater than 10% during the previous 6 months, signs of distant metastasis, and respiratory, renal, or heart disease
Sites / Locations
- Kochi Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
received programmed infusions of insulin determined by the control algorithm of the artificial pancreas
glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale
Outcomes
Primary Outcome Measures
the incidence of surgical site infection
Secondary Outcome Measures
the incidence of hypoglycemia and cost during the hospitalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00659698
Brief Title
Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection
Official Title
Prevention for Surgical Site Infection After Hepatic Resection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kochi University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluated that strict control of perioperative blood glucose following hepatic resection by using an artificial pancreas would improve postoperative surgical site infection.
Detailed Description
This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided patients into two groups: one for whom glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale and another that received programmed infusions of insulin determined by the control algorithm of the artificial pancreas.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases
Keywords
surgical, site, infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
received programmed infusions of insulin determined by the control algorithm of the artificial pancreas
Arm Title
2
Arm Type
No Intervention
Arm Description
glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale
Intervention Type
Device
Intervention Name(s)
the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
Other Intervention Name(s)
an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)
Intervention Description
artificial pancreas
Primary Outcome Measure Information:
Title
the incidence of surgical site infection
Time Frame
30th postoperative day
Secondary Outcome Measure Information:
Title
the incidence of hypoglycemia and cost during the hospitalization
Time Frame
during the hospitalization
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system.
Exclusion Criteria:
weight loss greater than 10% during the previous 6 months, signs of distant metastasis, and respiratory, renal, or heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takehiro Okabayashi, MD
Organizational Affiliation
Kochi Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Kochi Medical School
City
Nankoku-City
State/Province
Kochi
ZIP/Postal Code
783-8505
Country
Japan
12. IPD Sharing Statement
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Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection
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