Tight Glycemic Control by Artificial Pancreas (KMS)

Kochi University

Status: Unknown

Conditions: Cardiovascular Diseases; Pancreatic Disease

Treatments: Device: Artificial pancreas

Study type: Interventional

Funder types: Other

Identifiers

NCT00735228

Kochi Medical School

GCAP0802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

1

Active Comparator group

Description:

Perioperative blood glucose was controlled within the normal levels (80-110 mg/dL) by artificial pancreas.

Treatment:

Device: Artificial pancreas

2

Active Comparator group

Description:

Perioperative blood glucose concentration was controlled within the range from 140 to 160 mg/dL by artificial pancreas.

Treatment:

Device: Artificial pancreas