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Tight Glycemic Control by Artificial Pancreas

NCT00735228 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2008-08-18

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Artificial pancreas

Artificial endocrine pancreas (NIKKISO Company)

Sponsors & Collaborators

  • Oita University

    collaborator OTHER

  • University of Tokushima

    collaborator OTHER

  • Kochi University

    lead OTHER

Principal Investigators

  • Takehiro Okabayashi, MD, PhD · Kochi Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00735228 on ClinicalTrials.gov