NCT00735228

Tight Glycemic Control by Artificial Pancreas

Benefit of Tight Glycemic Control in Surgical Patients: Prospective Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Kochi University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Pancreatic Disease
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Artificial pancreas	Artificial endocrine pancreas (NIKKISO Company)

Timeline

• Start date: 2008-08-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2008-08-14
• Last updated: 2008-08-18

Locations

1 site across 1 country: Japan