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| ID | Type | Description | Link |
|---|---|---|---|
| S 51956 | Other Identifier | University Hospitals Leuven | |
| 80M0437 | Other Identifier | Belgian Federal Agency for Medicines and Health Products | |
| ML 6079 | Other Identifier | IRB |
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| Name | Class |
|---|---|
| Agency for Innovation by Science and Technology, Flanders, Belgium | UNKNOWN |
| Fund for Scientific Research, Flanders, Belgium | OTHER |
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The LOGIC-Insulin computerized software algorithm will be compared with a nurse-directed protocol, both targeting a blood glucose level of 80-110 mg/dL, in critically ill patients
Critical illness typically causes elevated blood glucose concentrations, which have been associated with increased mortality. Strictly normalizing these blood glucose levels by intensive insulin therapy, called tight glycemic control, decreased morbidity and mortality in well-controlled single-center clinical studies. However, multi-center pragmatic trials failed to reproduce those effects, proving that the implementation of tight glycemic control in daily clinical practice is rather difficult.
A computerized algorithm, amongst others, may help the nurses in the titration of insulin to reach normal blood glucose levels and to avoid the particularly worrisome hypoglycemia.
The LOGIC-1 study is a single blinded randomized controlled trial. On admission patients will be randomly assigned to either tight glycemic control (80-110 mg/dL) by the computerized LOGIC-Insulin 3.0 algorithm or to tight glycemic control (80-110 mg/dL) by the nurse-directed protocol. Written informed consent will be asked from the patient in the case of elective surgery requiring post-operative ICU-admission. Proxy informed consent from the closest family member will be asked when the patient was admitted to the ICU in emergency. As blood glucose control by itself is essential in the management of critical illness, random allocation will be done on admission and written informed consent from the closest family member can be deferred to a maximum of 24 hours after randomization. The patient or family member can at all times withdraw from the trial without impact on his treatment. Allocation will be done in blocks (block size is unknown to the care givers responsible for treatment allocation), stratified into cardiac surgery and other reasons for ICU admission, by central computer randomization.
The time window for the study will be 14 days starting from admission to the ICU or when one of the following stop criteria will be met:
Under the following conditions the study investigator/treating physician will be contacted and, if necessary, patients will be switched from LOGIC-Insulin to nurse-directed blood glucose control:
The common strategy for blood glucose control in both groups involves blood glucose measurements from arterial blood by a blood gas analyzer and the administration of insulin through a central line with a syringe pump.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LOGIC-Insulin | Experimental | Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm |
|
| Nurse-directed | Active Comparator | Nurse-directed blood glucose control (80-110 mg/dL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse directed | Procedure | Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Penalty Index (GPI) During the Intervention | The GPI is an index (ranging from 0 to 100) derived from the blood glucose values that are outside the target level of 80-110 mg/dL, in both the hyperglycemic and the hypoglycemic ranges. The weight of the penalty score of a blood glucose measurement is proportional to the level of deviation from normoglycemia. The GPI is the average of all penalties that are individually assigned to all blood glucose values, based on an optimized smooth penalty function. Higher GPI scores indicate lower efficacy of glycemic control. | The GPI is the average of all penalties that are individually assigned to all blood glucose values obtained up to 14 days post-randomization, based on an optimized smooth penalty function. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Severe Hypoglycemia (<40 mg/dL) During the Intervention | Proportion of patients to have had one or more episodes of severe hypoglycemia (<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 |
| Tom Van Herpe, Eng, PhD | KU Leuven | Principal Investigator |
| Bart De Moor, Eng, PhD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Intensive Care Medicine, University Hospitals Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11794168 | Background | van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300. | |
| 18302732 | Background | 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. |
| Label | URL |
|---|---|
| Leuven Laboratory Intensive Care Medicine | View source |
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Patients were recruited from 22 August 2011 to 16 December 2011 in a 56-bed ICU of a tertiary referral university hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | LOGIC-Insulin | Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm |
| FG001 | Nurse-directed | Nurse-directed blood glucose control (80-110 mg/dL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LOGIC-Insulin | Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm |
| BG001 | Nurse-directed | Nurse-directed blood glucose control (80-110 mg/dL) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycemic Penalty Index (GPI) During the Intervention | The GPI is an index (ranging from 0 to 100) derived from the blood glucose values that are outside the target level of 80-110 mg/dL, in both the hyperglycemic and the hypoglycemic ranges. The weight of the penalty score of a blood glucose measurement is proportional to the level of deviation from normoglycemia. The GPI is the average of all penalties that are individually assigned to all blood glucose values, based on an optimized smooth penalty function. Higher GPI scores indicate lower efficacy of glycemic control. | Posted | Median | Inter-Quartile Range | units on a scale | The GPI is the average of all penalties that are individually assigned to all blood glucose values obtained up to 14 days post-randomization, based on an optimized smooth penalty function. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LOGIC-Insulin | Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Greet Van den Berghe | Department and Laboratory of Intensive Care Medicine KULeuven/UZLeuven | 003216344017 | greet.vandenberghe@kuleuven.be |
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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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Algorithm-guided versus Nurse directed Blood Glucose Control
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| LOGIC-Insulin | Procedure | Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm |
|
|
Number of severe hypoglycemic 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 | up to 14 days post-randomization |
| Hyperglycemic Index (HGI) During the Intervention | Adequacy of reaching and maintaining the target range for blood glucose during the intervention | up to 14 days post-randomization |
| Daily Maximal Blood Glucose Difference During the Intervention | Marker of blood glucose variability | up to 14 days post-randomization |
| Proportion of Patients With Common Hypoglycemia (<60 mg/dL) During the Intervention | Proportion of patients to have had one or more episodes of common hypoglycemia during the intervention | up to 14 days post-randomization |
| Interval Between Blood Glucose Measurements During the Intervention | Marker of workload | up to 14 days post-randomization |
| Percentage of Time in Target Zone (80-110 mg/dL) During the Intervention | Adequacy of reaching and maintaining the target range for blood glucose during the intervention | up to 14 days post-randomization |
| Length of Stay in ICU | up to 90 days post-randomization |
| Length of Stay in Hospital | up to 90 days post-randomization |
| Hospital Mortality | Patients who will have been discharged from hospital before 90 days post-randomization will be regarded as survivors | up to 90 days post-randomization |
| Incidence of Common Hypoglycemia (<60 mg/dL) During the Intervention | Number of common hypoglycemic values as a fraction of all blood glucose measurements during the intervention | up to 14 days post-randomization |
| 19449617 | Background | Van Herpe T, De Moor B, Van den Berghe G. Towards closed-loop glycaemic control. Best Pract Res Clin Anaesthesiol. 2009 Mar;23(1):69-80. doi: 10.1016/j.bpa.2008.07.003. |
| 22961576 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI (kg/m²) | Mean | Standard Deviation | kg/m² |
|
| Apache II score (mean SD) | Acute Physiology and Chronic Health Evaluation (APACHE) II scores range from 0 to 71, with higher scores indicating a greater severity of illness | Mean | Standard Deviation | units on a scale |
|
| Admission type | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| OG001 | Nurse-directed | Nurse-directed blood glucose control (80-110 mg/dL) Nurse directed: Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL |
|
|
|
| Secondary | Proportion of Patients With Severe Hypoglycemia (<40 mg/dL) During the Intervention | Proportion of patients to have had one or more episodes of severe hypoglycemia (<40 mg/dL) during the intervention | Not Posted | up to 14 days post-randomization | Participants |
| Secondary | Incidence of Severe Hypoglycemia (<40 mg/dL) During the Intervention | Number of severe hypoglycemic values as a fraction of all blood glucose measurements during the intervention | Not Posted | up to 14 days post-randomization | Participants |
| Secondary | Blood Glucose Level Per Treatment Group During the Intervention | Not Posted | up to 14 days post-randomization | Participants |
| Secondary | Hyperglycemic Index (HGI) During the Intervention | Adequacy of reaching and maintaining the target range for blood glucose during the intervention | Not Posted | up to 14 days post-randomization | Participants |
| Secondary | Daily Maximal Blood Glucose Difference During the Intervention | Marker of blood glucose variability | Not Posted | up to 14 days post-randomization | Participants |
| Secondary | Proportion of Patients With Common Hypoglycemia (<60 mg/dL) During the Intervention | Proportion of patients to have had one or more episodes of common hypoglycemia during the intervention | Not Posted | up to 14 days post-randomization | Participants |
| Secondary | Interval Between Blood Glucose Measurements During the Intervention | Marker of workload | Not Posted | up to 14 days post-randomization | Participants |
| Secondary | Percentage of Time in Target Zone (80-110 mg/dL) During the Intervention | Adequacy of reaching and maintaining the target range for blood glucose during the intervention | Not Posted | up to 14 days post-randomization | Participants |
| Secondary | Length of Stay in ICU | Not Posted | up to 90 days post-randomization | Participants |
| Secondary | Length of Stay in Hospital | Not Posted | up to 90 days post-randomization | Participants |
| Secondary | Hospital Mortality | Patients who will have been discharged from hospital before 90 days post-randomization will be regarded as survivors | Not Posted | up to 90 days post-randomization | Participants |
| Secondary | Incidence of Common Hypoglycemia (<60 mg/dL) During the Intervention | Number of common hypoglycemic values as a fraction of all blood glucose measurements during the intervention | Not Posted | up to 14 days post-randomization | Participants |
| 19 |
| 149 |
| 0 |
| 149 |
| 0 |
| 149 |
| EG001 | Nurse-directed | Nurse-directed blood glucose control (80-110 mg/dL) | 10 | 151 | 0 | 151 | 0 | 151 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |