Tight Glycemic Control by Artificial Pancreas
Information source: Kochi University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Disease; Cardiovascular Diseases
Intervention: Artificial pancreas (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Kochi University Official(s) and/or principal investigator(s):
Takehiro Okabayashi, MD, PhD, Study Director, Affiliation: Kochi Medical School
Overall contact:
Takehiro Okabayashi, MD, PhD, Phone: +81-88-880-2370, Email: tokabaya@kochi-u.ac.jp
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.
Clinical Details
Official title: Benefit of Tight Glycemic Control in Surgical Patients: Prospective Randomized Clinical Trial
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The incidence of hypoglycemia
Secondary outcome: The incidence of postoperative infectious complications and calculate the total costs during hospitalization
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Takehiro Okabayashi, MD, PhD, Phone: +81-88-880-2370, Email: tokabaya@kochi-u.ac.jp
Kochi Medical School, Nankoku 783-8505, Japan; Recruiting
Takehiro Okabayashi, MD, PhD, Phone: +81-88-880-2370, Email: tokabaya@kochi-u.ac.jp
Kazuhiro Hanazaki, Prof, Phone: +81-88-880-2370, Email: im31@kochi-u.ac.jp
Takehiro Okabayashi, MD, PhD, Principal Investigator
Additional Information
Starting date: August 2008
Ending date: August 2012
Last updated: August 15, 2008
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