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| ID | Type | Description | Link |
|---|---|---|---|
| ML9517 | Other Identifier | IRB-BE | |
| S55613 | Other Identifier | University Hospitals Leuven | |
| 80M0563 | Other Identifier | FAMHP | |
| IWT-TBM 100793 | Other Grant/Funding Number | IWT-TBM |
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| Name | Class |
|---|---|
| Agentschap voor Innovatie door Wetenschap en Technologie | OTHER |
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Most critically ill patients are confronted with hyperglycaemia, which is associated with an increased mortality and morbidity risk. Normalising these elevated blood glucose levels by intensive insulin therapy may improve patient outcome, but is associated with an increased risk of hypoglycaemia. The LOGIC-2 study hypothesises that the LOGIC-Insulin computerised software algorithm will allow better (less hyperglycaemia) and safer (less hypoglycaemia) blood glucose control in critically ill patients than nurse-directed blood glucose control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse-directed | Active Comparator | Blood glucose control guided by paper protocol |
|
| LOGIC-Insulin | Experimental | Blood glucose control guided by the LOGIC-Insulin algorithm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOGIC-Insulin algorithm | Device |
| ||
| Paper protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Penalty Index (GPI) during the Intervention | Adequacy of reaching and maintaining the target range for blood glucose during the intervention (Effectiveness of glycaemic control) | up to 14 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Severe Hypoglycaemia (<40 mg/dL) during the Intervention | Proportion of patients to have had one or more episodes of severe hypoglycaemia (<40 mg/dL) during the intervention | up to 14 days post-randomization |
| Incidence of Severe Hypoglycemia (<40 mg/dL) during the Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Mesotten, MD, PhD | KU Leuven | Study Director |
| Greet Van den Berghe, MD, PhD | KU Leuven | Principal Investigator |
| Jasperina Dubois, MD | Jessa hospital, Hasselt | Principal Investigator |
| Marcus Schultz, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Hospital | Hasselt | 3500 | Belgium | |||
| Dept Intensive Care Medicine, University Hospitals Leuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22961576 | Background | Van Herpe T, Mesotten D, Wouters PJ, Herbots J, Voets E, Buyens J, De Moor B, Van den Berghe G. LOGIC-insulin algorithm-guided versus nurse-directed blood glucose control during critical illness: the LOGIC-1 single-center, randomized, controlled clinical trial. Diabetes Care. 2013 Feb;36(2):188-94. doi: 10.2337/dc12-0584. Epub 2012 Sep 6. | |
| 18302732 |
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|
Number of severe hypoglycaemic values as a fraction of all blood glucose measurements during the intervention |
| up to 14 days post-randomization |
| Blood Glucose Level Per Treatment Group during the Intervention | Mean and median arterial blood glucose level | up to 14 days post-randomization |
| Hyperglycaemic index (HGI) | Adequacy of reaching and maintaining the target range for blood glucose, as assessed by the Hyperglycaemic index (HGI) | up to 14 days post-randomization |
| Time in target range | up to 14 days post-randomization |
| Time to target range | up to 14 days post-randomization |
| Daily maximal blood glucose difference | marker of blood glucose fluctuations | up to 14 days post-randomization |
| Incidence of mild hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention | Number of mild hypoglycaemic values as a fraction of all blood glucose measurements during the intervention | up to 14 days post-randomization |
| Proportion of Patients With Mild Hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention | Proportion of patients to have had one or more episodes of mild hypoglycaemia during the intervention | up to 14 days post-randomization |
| Interval between blood glucose measurements | marker of workload | up to 14 days post-randomization |
| Protocol compliance in the intervention group | the number and proportion of patients in which the LOGIC-Insulin was not followed for a time period of at least 8 hours, which is the duration of one nurse shift. | up to 14 days post-randomization |
| Overrules in the intervention group | the number and proportions of recommendations by the software that were overruled by the bed-side nurses
| up to 14 days post-randomization |
| Incidence of new infections in the ICU | The diagnosis of "new infection" will be based on the administration of antibiotics, beyond the prophylactic scope | up to 90 days post-randomization |
| Length of stay in the ICU | up to 90 days post-randomization |
| Length of stay in the hospital | up to 90 days post-randomization |
| Mortality in the ICU | up to 90 days post-randomization |
| Mortality in the hospital | up to 90 days post-randomization |
| Landmark 90-day mortality | up to 90 days post-randomization |
| All direct medical costs from a healthcare payer's perspective | up to 90 days post-randomization |
| Quality of Life | EuroQol-5D | up to 90 days post-randomization |
| Leuven |
| 3000 |
| Belgium |
| Medical Intensive Care, University Hospitals Leuven | Leuven | 3000 | Belgium |
| Academic Medical Center (AMC) | Amsterdam | 1105 | Netherlands |
| Van Herpe T, De Brabanter J, Beullens M, De Moor B, Van den Berghe G. Glycemic penalty index for adequately assessing and comparing different blood glucose control algorithms. Crit Care. 2008;12(1):R24. doi: 10.1186/cc6800. Epub 2008 Feb 26. |
| 19531590 | Background | Van den Berghe G, Schetz M, Vlasselaers D, Hermans G, Wilmer A, Bouillon R, Mesotten D. Clinical review: Intensive insulin therapy in critically ill patients: NICE-SUGAR or Leuven blood glucose target? J Clin Endocrinol Metab. 2009 Sep;94(9):3163-70. doi: 10.1210/jc.2009-0663. Epub 2009 Jun 16. |
| 28806982 | Derived | Dubois J, Van Herpe T, van Hooijdonk RT, Wouters R, Coart D, Wouters P, Van Assche A, Veraghtert G, De Moor B, Wauters J, Wilmer A, Schultz MJ, Van den Berghe G, Mesotten D. Software-guided versus nurse-directed blood glucose control in critically ill patients: the LOGIC-2 multicenter randomized controlled clinical trial. Crit Care. 2017 Aug 14;21(1):212. doi: 10.1186/s13054-017-1799-6. |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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