Tight Glycemic Control by Artificial Pancreas - Full Text View

Sponsor:	Kochi University
Collaborators:	Oita University University of Tokushima
Information provided by:	Kochi University
ClinicalTrials.gov Identifier:	NCT00735228

Purpose

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.

Condition	Intervention
Pancreatic Disease Cardiovascular Diseases	Device: Artificial pancreas

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Benefit of Tight Glycemic Control in Surgical Patients: Prospective Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Pancreatic Diseases Surgery

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by Kochi University:

Primary Outcome Measures:

The incidence of hypoglycemia [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The incidence of postoperative infectious complications and calculate the total costs during hospitalization [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Perioperative blood glucose was controlled within the normal levels (80-110 mg/dL) by artificial pancreas.	Device: Artificial pancreas Artificial endocrine pancreas (NIKKISO Company)
2: Active Comparator Perioperative blood glucose concentration was controlled within the range from 140 to 160 mg/dL by artificial pancreas.	Device: Artificial pancreas Artificial endocrine pancreas (NIKKISO Company)

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735228

Contacts

Contact: Takehiro Okabayashi, MD, PhD	+81-88-880-2370	tokabaya@kochi-u.ac.jp
Contact: Kazuhiro Hanazaki, Prof	+81-88-880-2370	im31@kochi-u.ac.jp

Locations

Japan
Kochi Medical School	Recruiting
Nankoku, Japan, 783-8505
Contact: Takehiro Okabayashi, MD, PhD +81-88-880-2370 tokabaya@kochi-u.ac.jp
Contact: Kazuhiro Hanazaki, Prof +81-88-880-2370 im31@kochi-u.ac.jp
Principal Investigator: Takehiro Okabayashi, MD, PhD

Sponsors and Collaborators

Kochi University

Oita University

University of Tokushima

Investigators

Study Director:

Takehiro Okabayashi, MD, PhD

Kochi Medical School

More Information

No publications provided

Responsible Party:	Kochi University ( Kochi Medical School )
Study ID Numbers:	GCAP0802, Kochi Medical School
Study First Received:	August 12, 2008
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00735228 History of Changes
Health Authority:	Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Kochi University:

surgery
artificial pancreas
tight glycemic control
Liver

Additional relevant MeSH terms:

Digestive System Diseases
Therapeutic Uses
Gastrointestinal Agents
Pancreatic Diseases

Cardiovascular Diseases
Pancrelipase
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010