Multicentre LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (LOGIC-2)

Critical Illness Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056353
• Other study ID #: LOGIC-Insulin 2.1.1
• Secondary ID: ML9517S5561380M0
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: January 7, 2016
• Start date: February 2014
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1550
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Hyperglycemia
• Hypoglycemia

Intervention

Device:
• LOGIC-Insulin algorithm

• Paper protocol

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt
Belgium	Dept Intensive Care Medicine, University Hospitals Leuven	Leuven
Belgium	Medical Intensive Care, University Hospitals Leuven	Leuven
Netherlands	Academic Medical Center (AMC)	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Agentschap voor Innovatie door Wetenschap en Technologie

Countries where clinical trial is conducted

Belgium,  Netherlands, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	up to 14 days post-randomization	Yes
Secondary	Blood Glucose Level Per Treatment Group during the Intervention	Mean and median arterial blood glucose level	up to 14 days post-randomization	No
Secondary	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	No
Secondary	Time in target range		up to 14 days post-randomization	No
Secondary	Time to target range		up to 14 days post-randomization	No
Secondary	Daily maximal blood glucose difference	marker of blood glucose fluctuations	up to 14 days post-randomization	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Interval between blood glucose measurements	marker of workload	up to 14 days post-randomization	No
Secondary	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	No
Secondary	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	up to 14 days post-randomization	Yes
Secondary	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	No
Secondary	Length of stay in the ICU		up to 90 days post-randomization	No
Secondary	Length of stay in the hospital		up to 90 days post-randomization	No
Secondary	Mortality in the ICU		up to 90 days post-randomization	Yes
Secondary	Mortality in the hospital		up to 90 days post-randomization	Yes
Secondary	Landmark 90-day mortality		up to 90 days post-randomization	Yes
Secondary	All direct medical costs from a healthcare payer's perspective		up to 90 days post-randomization	No
Secondary	Quality of Life	EuroQol-5D	up to 90 days post-randomization	No