Multicentre LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (LOGIC-2)
- Conditions
- HyperglycemiaCritical IllnessHypoglycemia
- Interventions
- Device: LOGIC-Insulin algorithmDevice: Paper protocol
- Registration Number
- NCT02056353
- Lead Sponsor
- KU Leuven
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1550
- Patients admitted to the ICU with an expected stay of at least 48 hours and already receiving or potentially needing insulin infusion for blood glucose control. These patients should already have or need an arterial and central venous line
- Patients should be 18 years or older
- Not critically ill
- Age under 18 years
- Patients already enrolled in another intervention randomized controlled trial
- Patients expected to die within 12 hours (=moribund patients)
- No arterial line or central venous line needed
- Pregnancy or lactating
- Patients suffering from ketoacidotic or hyperosmolar coma on admission
- Patients who have been previously been included in the LOGIC-2 study
- Allergy to insulin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LOGIC-Insulin LOGIC-Insulin algorithm Blood glucose control guided by the LOGIC-Insulin algorithm Nurse-directed Paper protocol Blood glucose control guided by paper protocol
- Primary Outcome Measures
Name Time Method Glycemic Penalty Index (GPI) during the Intervention up to 14 days post-randomization Adequacy of reaching and maintaining the target range for blood glucose during the intervention (Effectiveness of glycaemic control)
- Secondary Outcome Measures
Name Time Method Proportion of Patients With Severe Hypoglycaemia (<40 mg/dL) during the Intervention up to 14 days post-randomization Proportion of patients to have had one or more episodes of severe hypoglycaemia (\<40 mg/dL) during the intervention
Incidence of Severe Hypoglycemia (<40 mg/dL) during the Intervention up to 14 days post-randomization Number of severe hypoglycaemic values as a fraction of all blood glucose measurements during the intervention
Blood Glucose Level Per Treatment Group during the Intervention up to 14 days post-randomization Mean and median arterial blood glucose level
Hyperglycaemic index (HGI) up to 14 days post-randomization Adequacy of reaching and maintaining the target range for blood glucose, as assessed by the Hyperglycaemic index (HGI)
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 up to 14 days post-randomization marker of blood glucose fluctuations
Incidence of mild hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention up to 14 days post-randomization Number of mild hypoglycaemic values as a fraction of all blood glucose measurements during the intervention
Proportion of Patients With Mild Hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention up to 14 days post-randomization Proportion of patients to have had one or more episodes of mild hypoglycaemia during the intervention
Interval between blood glucose measurements up to 14 days post-randomization marker of workload
Protocol compliance in the intervention group up to 14 days post-randomization 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.
Overrules in the intervention group up to 14 days post-randomization 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 assessedIncidence of new infections in the ICU up to 90 days post-randomization The diagnosis of "new infection" will be based on the administration of antibiotics, beyond the prophylactic scope
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 up to 90 days post-randomization EuroQol-5D
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
Trial Locations
- Locations (4)
Dept Intensive Care Medicine, University Hospitals Leuven
🇧🇪Leuven, Belgium
Academic Medical Center (AMC)
🇳🇱Amsterdam, Netherlands
Jessa Hospital
🇧🇪Hasselt, Belgium
Medical Intensive Care, University Hospitals Leuven
🇧🇪Leuven, Belgium