Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection

Liver Diseases Clinical Trial

Official title:

Prevention for Surgical Site Infection After Hepatic Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659698
• Other study ID #: TGC-AP-02
• Secondary ID: Kochi University
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2008
• Last updated: April 15, 2008
• Start date: April 2007
• Est. completion date: April 2008

Study information

• Verified date: April 2008
• Source: Kochi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Device:
• the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
artificial pancreas

Locations

Country	Name	City	State
Japan	Kochi Medical School	Nankoku-City	Kochi

Sponsors (1)

Lead Sponsor	Collaborator
Kochi University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of surgical site infection		30th postoperative day
Secondary	the incidence of hypoglycemia and cost during the hospitalization		during the hospitalization