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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,550
Jessa Hospital
Hasselt, Belgium
Dept Intensive Care Medicine, University Hospitals Leuven
Leuven, Belgium
Medical Intensive Care, University Hospitals Leuven
Leuven, Belgium
Academic Medical Center (AMC)
Amsterdam, Netherlands
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)
Time frame: up to 14 days post-randomization
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
Time frame: up to 14 days post-randomization
Incidence of Severe Hypoglycemia (<40 mg/dL) during the Intervention
Number of severe hypoglycaemic values as a fraction of all blood glucose measurements during the intervention
Time frame: up to 14 days post-randomization
Blood Glucose Level Per Treatment Group during the Intervention
Mean and median arterial blood glucose level
Time frame: 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)
Time frame: up to 14 days post-randomization
Time in target range
Time frame: up to 14 days post-randomization
Time to target range
Time frame: up to 14 days post-randomization
Daily maximal blood glucose difference
marker of blood glucose fluctuations
Time frame: 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
Time frame: 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
Time frame: up to 14 days post-randomization
Interval between blood glucose measurements
marker of workload
Time frame: 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.
Time frame: 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 * Minor overrules: absolute insulin dose difference of \>0.1 and \< 1IU/h * Major overrules: absolute insulin dose difference of \>= 1IU/h * Major overrules will also be qualitatively assessed
Time frame: 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
Time frame: up to 90 days post-randomization
Length of stay in the ICU
Time frame: up to 90 days post-randomization
Length of stay in the hospital
Time frame: up to 90 days post-randomization
Mortality in the ICU
Time frame: up to 90 days post-randomization
Mortality in the hospital
Time frame: up to 90 days post-randomization
Landmark 90-day mortality
Time frame: up to 90 days post-randomization
All direct medical costs from a healthcare payer's perspective
Time frame: up to 90 days post-randomization
Quality of Life
EuroQol-5D
Time frame: up to 90 days post-randomization
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