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Tight Glycemic Control by Artificial Pancreas (KMS)

Primary Purpose

Pancreatic Disease, Cardiovascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Artificial pancreas
Sponsored by
Kochi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Disease focused on measuring surgery, artificial pancreas, tight glycemic control, Liver

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kochi Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Perioperative blood glucose was controlled within the normal levels (80-110 mg/dL) by artificial pancreas.

Perioperative blood glucose concentration was controlled within the range from 140 to 160 mg/dL by artificial pancreas.

Outcomes

Primary Outcome Measures

The incidence of hypoglycemia

Secondary Outcome Measures

The incidence of postoperative infectious complications and calculate the total costs during hospitalization

Full Information

First Posted
August 12, 2008
Last Updated
August 15, 2008
Sponsor
Kochi University
Collaborators
Oita University, University of Tokushima
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1. Study Identification

Unique Protocol Identification Number
NCT00735228
Brief Title
Tight Glycemic Control by Artificial Pancreas
Acronym
KMS
Official Title
Benefit of Tight Glycemic Control in Surgical Patients: Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kochi University
Collaborators
Oita University, University of Tokushima

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Disease, Cardiovascular Diseases
Keywords
surgery, artificial pancreas, tight glycemic control, Liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Perioperative blood glucose was controlled within the normal levels (80-110 mg/dL) by artificial pancreas.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Perioperative blood glucose concentration was controlled within the range from 140 to 160 mg/dL by artificial pancreas.
Intervention Type
Device
Intervention Name(s)
Artificial pancreas
Other Intervention Name(s)
artificial endocrine pancreas (NIKKISO Company)
Intervention Description
Artificial endocrine pancreas (NIKKISO Company)
Primary Outcome Measure Information:
Title
The incidence of hypoglycemia
Time Frame
during hospitalization
Secondary Outcome Measure Information:
Title
The incidence of postoperative infectious complications and calculate the total costs during hospitalization
Time Frame
during hospitalization

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takehiro Okabayashi, MD, PhD
Phone
+81-88-880-2370
Email
tokabaya@kochi-u.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Kazuhiro Hanazaki, Prof
Phone
+81-88-880-2370
Email
im31@kochi-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takehiro Okabayashi, MD, PhD
Organizational Affiliation
Kochi Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Kochi Medical School
City
Nankoku
ZIP/Postal Code
783-8505
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takehiro Okabayashi, MD, PhD
Phone
+81-88-880-2370
Email
tokabaya@kochi-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Kazuhiro Hanazaki, Prof
Phone
+81-88-880-2370
Email
im31@kochi-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Takehiro Okabayashi, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
24623024
Citation
Okabayashi T, Shima Y, Sumiyoshi T, Kozuki A, Tokumaru T, Iiyama T, Sugimoto T, Kobayashi M, Yokoyama M, Hanazaki K. Intensive versus intermediate glucose control in surgical intensive care unit patients. Diabetes Care. 2014 Jun;37(6):1516-24. doi: 10.2337/dc13-1771. Epub 2014 Mar 12.
Results Reference
derived

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Tight Glycemic Control by Artificial Pancreas

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