Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection - Full Text View

Sponsor:	Kochi University
Information provided by:	Kochi University
ClinicalTrials.gov Identifier:	NCT00659698

Purpose

This study evaluated that strict control of perioperative blood glucose following hepatic resection by using an artificial pancreas would improve postoperative surgical site infection.

Condition	Intervention	Phase
Liver Diseases	Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Prevention for Surgical Site Infection After Hepatic Resection

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by Kochi University:

Primary Outcome Measures:

the incidence of surgical site infection [ Time Frame: 30th postoperative day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

the incidence of hypoglycemia and cost during the hospitalization [ Time Frame: during the hospitalization ] [ Designated as safety issue: Yes ]

Enrollment:	70
Study Start Date:	April 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 received programmed infusions of insulin determined by the control algorithm of the artificial pancreas	Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan) artificial pancreas Other Name: an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)
No Intervention: 2 glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659698

Locations

Japan
Kochi Medical School
Nankoku-City, Kochi, Japan, 783-8505

Sponsors and Collaborators

Kochi University

Investigators

Study Director:

Takehiro Okabayashi, MD

Kochi Medical School

More Information

No publications provided

Responsible Party:	Kochi University, Kochi Medical School
ClinicalTrials.gov Identifier:	NCT00659698 History of Changes
Other Study ID Numbers:	TGC-AP-02, Kochi University
Study First Received:	April 11, 2008
Last Updated:	April 15, 2008
Health Authority:	Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Kochi University:

surgical
site
infection

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Pancrelipase

Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012