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Tight Glycemic Control by Artificial Pancreas (KMS)

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ClinicalTrials.gov Identifier: NCT00735228
Recruitment Status : Unknown
Verified August 2008 by Kochi University.
Recruitment status was:  Recruiting
First Posted : August 14, 2008
Last Update Posted : August 18, 2008
Sponsor:
Collaborators:
Oita University
University of Tokushima
Information provided by:
Kochi University

August 12, 2008
August 14, 2008
August 18, 2008
August 2008
August 2012   (Final data collection date for primary outcome measure)
The incidence of hypoglycemia [ Time Frame: during hospitalization ]
Same as current
Complete list of historical versions of study NCT00735228 on ClinicalTrials.gov Archive Site
The incidence of postoperative infectious complications and calculate the total costs during hospitalization [ Time Frame: during hospitalization ]
the incidence of postioerative infectious complications and caluculate the total costs during hospitalization [ Time Frame: during hospitalization ]
Not Provided
Not Provided
 
Tight Glycemic Control by Artificial Pancreas
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pancreatic Disease
  • Cardiovascular Diseases
Device: Artificial pancreas
Artificial endocrine pancreas (NIKKISO Company)
Other Name: artificial endocrine pancreas (NIKKISO Company)
  • Active Comparator: 1
    Perioperative blood glucose was controlled within the normal levels (80-110 mg/dL) by artificial pancreas.
    Intervention: Device: Artificial pancreas
  • Active Comparator: 2
    Perioperative blood glucose concentration was controlled within the range from 140 to 160 mg/dL by artificial pancreas.
    Intervention: Device: Artificial pancreas
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
400
Same as current
August 2012
August 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00735228
GCAP0802
Kochi Medical School
Yes
Not Provided
Not Provided
Kochi Medical School, Kochi University
Kochi University
  • Oita University
  • University of Tokushima
Study Director: Takehiro Okabayashi, MD, PhD Kochi Medical School
Kochi University
August 2008

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