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Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659698
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
Sponsor:
Information provided by:
Kochi University

Tracking Information
First Submitted Date  ICMJE April 11, 2008
First Posted Date  ICMJE April 16, 2008
Last Update Posted Date April 16, 2008
Study Start Date  ICMJE April 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2008)
the incidence of surgical site infection [ Time Frame: 30th postoperative day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2008)
the incidence of hypoglycemia and cost during the hospitalization [ Time Frame: during the hospitalization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection
Official Title  ICMJE Prevention for Surgical Site Infection After Hepatic Resection
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Liver Diseases
Intervention  ICMJE Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
artificial pancreas
Other Name: an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)
Study Arms  ICMJE
  • Experimental: 1
    received programmed infusions of insulin determined by the control algorithm of the artificial pancreas
    Intervention: Device: the closed-loop STG-22 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2008)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00659698
Other Study ID Numbers  ICMJE TGC-AP-02
Kochi University
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kochi University, Kochi Medical School
Study Sponsor  ICMJE Kochi University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Takehiro Okabayashi, MD Kochi Medical School
PRS Account Kochi University
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP