Tight Glycemic Control by Artificial Pancreas
KMS
Benefit of Tight Glycemic Control in Surgical Patients: Prospective Randomized Clinical Trial
2 other identifiers
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 12, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedAugust 18, 2008
August 1, 2008
4 years
August 12, 2008
August 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of hypoglycemia
during hospitalization
Secondary Outcomes (1)
The incidence of postoperative infectious complications and calculate the total costs during hospitalization
during hospitalization
Study Arms (2)
1
ACTIVE COMPARATORPerioperative blood glucose was controlled within the normal levels (80-110 mg/dL) by artificial pancreas.
2
ACTIVE COMPARATORPerioperative blood glucose concentration was controlled within the range from 140 to 160 mg/dL by artificial pancreas.
Interventions
Artificial endocrine pancreas (NIKKISO Company)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- The presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kochi Universitylead
- Oita Universitycollaborator
- University of Tokushimacollaborator
Study Sites (1)
Kochi Medical School
Nankoku, 783-8505, Japan
Related Publications (1)
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.
PMID: 24623024DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Takehiro Okabayashi, MD, PhD
Kochi Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 12, 2008
First Posted
August 14, 2008
Study Start
August 1, 2008
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
August 18, 2008
Record last verified: 2008-08