Clinical trial NCT02056353: Multicentre LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (LOGIC-2)
Official title: LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-2 Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Hyperglycemia
Hypoglycemia
Keywords: Software
Algorithm
Cardiac surgery
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2014-02-06
Enrollment: 1550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Glycemic Penalty Index (GPI) during the Intervention
timeFrame: up to 14 days post-randomization
Secondary outcomes:
measure: Proportion of Patients With Severe Hypoglycaemia (<40 mg/dL) during the Intervention
timeFrame: up to 14 days post-randomization
measure: Incidence of Severe Hypoglycemia (<40 mg/dL) during the Intervention
timeFrame: up to 14 days post-randomization
measure: Blood Glucose Level Per Treatment Group during the Intervention
timeFrame: up to 14 days post-randomization
measure: Hyperglycaemic index (HGI)
timeFrame: up to 14 days post-randomization
measure: Time in target range
timeFrame: up to 14 days post-randomization
measure: Time to target range
timeFrame: up to 14 days post-randomization
measure: Daily maximal blood glucose difference
timeFrame: up to 14 days post-randomization
measure: Incidence of mild hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention
timeFrame: up to 14 days post-randomization
measure: Proportion of Patients With Mild Hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention
timeFrame: up to 14 days post-randomization
measure: Interval between blood glucose measurements
timeFrame: up to 14 days post-randomization
measure: Protocol compliance in the intervention group
timeFrame: up to 14 days post-randomization
measure: Overrules in the intervention group
timeFrame: up to 14 days post-randomization
measure: Incidence of new infections in the ICU
timeFrame: up to 90 days post-randomization
measure: Length of stay in the ICU
timeFrame: up to 90 days post-randomization
measure: Length of stay in the hospital
timeFrame: up to 90 days post-randomization
measure: Mortality in the ICU
timeFrame: up to 90 days post-randomization
measure: Mortality in the hospital
timeFrame: up to 90 days post-randomization
measure: Landmark 90-day mortality
timeFrame: up to 90 days post-randomization
measure: All direct medical costs from a healthcare payer's perspective
timeFrame: up to 90 days post-randomization
measure: Quality of Life
timeFrame: up to 90 days post-randomization
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Leuven
country: Belgium
facility: Dept Intensive Care Medicine, University Hospitals Leuven
city: Leuven
country: Belgium
facility: Medical Intensive Care, University Hospitals Leuven
city: Amsterdam
country: Netherlands
facility: Academic Medical Center (AMC)
Study officials:
affiliation: KU Leuven
name: Dieter Mesotten, MD, PhD
role: STUDY_DIRECTOR
affiliation: KU Leuven
name: Greet Van den Berghe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jessa hospital, Hasselt
name: Jasperina Dubois, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Marcus Schultz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.