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Tight Glycemic Control by Artificial Pancreas

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00735228
Acronym
KMS
Enrollment
400
Registered
2008-08-14
Start date
2008-08-31
Completion date
2012-08-31
Last updated
2008-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Disease, Cardiovascular Diseases

Keywords

surgery, artificial pancreas, tight glycemic control, Liver

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.

Interventions

Artificial endocrine pancreas (NIKKISO Company)

Sponsors

Oita University
CollaboratorOTHER
University of Tokushima
CollaboratorOTHER
Kochi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
The incidence of hypoglycemiaduring hospitalization

Secondary

MeasureTime frame
The incidence of postoperative infectious complications and calculate the total costs during hospitalizationduring hospitalization

Countries

Japan

Contacts

Primary ContactTakehiro Okabayashi, MD, PhD
tokabaya@kochi-u.ac.jp+81-88-880-2370
Backup ContactKazuhiro Hanazaki, Prof
im31@kochi-u.ac.jp+81-88-880-2370

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026