Tight Glycemic Control by Artificial Pancreas

Cardiovascular Diseases Clinical Trial

— KMS  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00735228
• Other study ID #: GCAP0802
• Secondary ID: Kochi Medical Sc
• Status: Unknown status
• Phase: N/A
• First received: August 12, 2008
• Last updated: August 15, 2008
• Start date: August 2008
• Est. completion date: August 2012

Study information

• Verified date: August 2008
• Source: Kochi University
• Contact: Takehiro Okabayashi, MD, PhD
• Phone: +81-88-880-2370
• Email: tokabaya[@]kochi-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 400
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Pancreatic Disease
• Pancreatic Diseases

Intervention

Device:
• Artificial pancreas
Artificial endocrine pancreas (NIKKISO Company)

Locations

Country	Name	City	State
Japan	Kochi Medical School	Nankoku

Sponsors (3)

Lead Sponsor	Collaborator
Kochi University	Oita University, University of Tokushima

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of hypoglycemia		during hospitalization
Secondary	The incidence of postoperative infectious complications and calculate the total costs during hospitalization		during hospitalization