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Tight Glycemic Control by Artificial Pancreas

NCT ID: NCT00735228

Last Updated: 2008-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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

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Pancreatic Disease Cardiovascular Diseases

Keywords

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surgery artificial pancreas tight glycemic control Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Artificial pancreas

Intervention Type DEVICE

Artificial endocrine pancreas (NIKKISO Company)

2

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

Group Type ACTIVE_COMPARATOR

Artificial pancreas

Intervention Type DEVICE

Artificial endocrine pancreas (NIKKISO Company)

Interventions

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Artificial pancreas

Artificial endocrine pancreas (NIKKISO Company)

Intervention Type DEVICE

Other Intervention Names

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artificial endocrine pancreas (NIKKISO Company)

Eligibility Criteria

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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

* The presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oita University

OTHER

Sponsor Role collaborator

University of Tokushima

OTHER

Sponsor Role collaborator

Kochi University

OTHER

Sponsor Role lead

Responsible Party

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Kochi University

Principal Investigators

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Takehiro Okabayashi, MD, PhD

Role: STUDY_DIRECTOR

Kochi Medical School

Locations

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Kochi Medical School

Nankoku, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Takehiro Okabayashi, MD, PhD

Role: CONTACT

Phone: +81-88-880-2370

Email: [email protected]

Kazuhiro Hanazaki, Prof

Role: CONTACT

Phone: +81-88-880-2370

Email: [email protected]

Facility Contacts

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Takehiro Okabayashi, MD, PhD

Role: primary

Kazuhiro Hanazaki, Prof

Role: backup

References

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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.

Reference Type DERIVED
PMID: 24623024 (View on PubMed)

Other Identifiers

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Kochi Medical School

Identifier Type: -

Identifier Source: secondary_id

GCAP0802

Identifier Type: -

Identifier Source: org_study_id