Tight Glycemic Control by Artificial Pancreas (KMS)

August 15, 2008 updated by: Kochi University

Benefit of Tight Glycemic Control in Surgical Patients: Prospective Randomized Clinical Trial

Hyperglycaemia has been repeatedly associated with risk of mortality and morbidity in the intensive care unit (ICU). The evidence currently available is in favour of a 'normal ≤ 6.1 mmol/l' level for blood glucose control in ICUs according to two large randomized control trials of Van den Berghe G and is not supportive of J. Miles's viewpoint in this debate. In this study, the investigators would like to evaluate that the target of blood glucose level, whether is a normal level (80-110 mg/dL) or another level (140-160 mg/dL), should be set for the reduction of perioperative mortality and complications.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Our previous prospective randomized clinical trial suggested that the postoperative morbidities were reduced by tight glycemic control of a normal level for blood glucose using artificial pancreas. However, the most feared one is hypoglycaemia, which, when severe and prolonged, may cause convulsions, coma and brain damage, as well as cardiac arrhythmias. Recently, Ven den Berghe G report that the development of accurate, continuous blood glucose monitoring devices, and preferably closed-loop systems for computer-assisted blood glucose control in the ICU, will help to avoid hypoglycaemia. In our study, no hypoglycemia showed in more than 100 patients who performed perioperative tight glycemic control by artificial pancreas.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Nankoku, Japan, 783-8505
        • Recruiting
        • Kochi Medical School
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takehiro Okabayashi, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who were suffering from liver, pancreas or cardio-vascular diseases, were informed of the purpose and details of the study, and written consent was obtained from them prior to enrolment.

Exclusion Criteria:

  • Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery
  • The presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Perioperative blood glucose was controlled within the normal levels (80-110 mg/dL) by artificial pancreas.
Device: Artificial pancreas
Artificial endocrine pancreas (NIKKISO Company)
Other Names:
  • artificial endocrine pancreas (NIKKISO Company)
Active Comparator: 2
Perioperative blood glucose concentration was controlled within the range from 140 to 160 mg/dL by artificial pancreas.
Device: Artificial pancreas
Artificial endocrine pancreas (NIKKISO Company)
Other Names:
  • artificial endocrine pancreas (NIKKISO Company)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of hypoglycemia
Time Frame: during hospitalization
during hospitalization

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of postoperative infectious complications and calculate the total costs during hospitalization
Time Frame: during hospitalization
during hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kochi University

Collaborators

University of Tokushima
Oita University

Investigators

  • Study Director: Takehiro Okabayashi, MD, PhD, Kochi Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

August 18, 2008

Last Update Submitted That Met QC Criteria

August 15, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCAP0802
  • Kochi Medical School

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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