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Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. Space GlucoseControl (TGC system) is a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges. Information on parenteral and enteral nutrition is automatically integrated into the calculations. The primary objective of the current study is to investigate the performance and usability of the Space TGC system for glucose control over an tight glucose control range (4.4 to 6.1 mmol/L) in surgical intensive care patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Space TGC system with incorporated eMPC advised insulin titration to establish tight glycaemic control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Space TGC | Device | Space TGC with incorporated eMPC algorithm to establish tight glycaemic control with a blood glucose target range of 80-110 mg/dL (4.4-6.1 mM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| (Arterial) blood glucose values -> percentage of time within predefined glucose target range 80-110 mg/dL (4.4-6.1 mM) | all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 72h |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycaemia ≤ 40 md/dL (2.2mM) | from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 72h | |
| Usability parameters like convenience of alarming function; workload; blood sampling frequency |
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Boldt, Prof. Dr. med. | Klinik für Anästhesiologie und Operative Intensivmedizin, Klinikum Ludwigshafen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Ludwigshafen am Rhein gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin | Ludwigshafen | 67063 | Germany |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
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| from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 72h |
| Concomitant medication including insulin infusion rate, parenteral/enteral nutrition | from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 72h |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |