Clinical trial NCT00735228: Tight Glycemic Control by Artificial Pancreas
Official title: Benefit of Tight Glycemic Control in Surgical Patients: Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Disease
Cardiovascular Diseases
Keywords: surgery
artificial pancreas
tight glycemic control
Liver
Lead sponsor: Kochi University
Sponsor class: OTHER
Collaborators: name: Oita University
name: University of Tokushima
First posted: 2008-08-14
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The incidence of hypoglycemia
timeFrame: during hospitalization
Secondary outcomes:
measure: The incidence of postoperative infectious complications and calculate the total costs during hospitalization
timeFrame: during hospitalization
Other outcomes:
Locations:
city: Nankoku
country: Japan
facility: Kochi Medical School
Study officials:
affiliation: Kochi Medical School
name: Takehiro Okabayashi, MD, PhD
role: STUDY_DIRECTOR
References:
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.