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| ID | Type | Description | Link |
|---|---|---|---|
| Kochi Medical School |
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| Name | Class |
|---|---|
| Oita University | OTHER |
| University of Tokushima | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Perioperative blood glucose was controlled within the normal levels (80-110 mg/dL) by artificial pancreas. |
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| 2 | Active Comparator | Perioperative blood glucose concentration was controlled within the range from 140 to 160 mg/dL by artificial pancreas. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial pancreas | Device | Artificial endocrine pancreas (NIKKISO Company) |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence of hypoglycemia | during hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative infectious complications and calculate the total costs during hospitalization | during hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takehiro Okabayashi, MD, PhD | Contact | +81-88-880-2370 | tokabaya@kochi-u.ac.jp | |
| Kazuhiro Hanazaki, Prof | Contact | +81-88-880-2370 | im31@kochi-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Takehiro Okabayashi, MD, PhD | Kochi Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kochi Medical School | Recruiting | Nankoku | 783-8505 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24623024 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 5, 2012 | |
| Reset | Oct 4, 2012 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 5, 2012 | Oct 4, 2012 |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019397 | Pancreas, Artificial |
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D016503 | Drug Delivery Systems |
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| D004358 |
| Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |