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

NCT02056353 | Completed DMC

• 5 other identifiers: LOGIC-Insulin 2.1.1ML9517S5561380M0563IWT-TBM 100793
• Study Type: interventional
• Target: 1,550
• Locations: 2 countries
• Sites: 4

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.

Conditions

Critical Illness; Hyperglycemia; Hypoglycemia

Keywords

Software; Algorithm; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (20)

• Proportion of Patients With Severe Hypoglycaemia (<40 mg/dL) during the Intervention

  up to 14 days post-randomization

• Incidence of Severe Hypoglycemia (<40 mg/dL) during the Intervention

  up to 14 days post-randomization

• Blood Glucose Level Per Treatment Group during the Intervention

  up to 14 days post-randomization

• Hyperglycaemic index (HGI)

  up to 14 days post-randomization

• Time in target range

  up to 14 days post-randomization

Study Arms (2)

Nurse-directed

ACTIVE COMPARATOR

Blood glucose control guided by paper protocol

Device: Paper protocol

LOGIC-Insulin

EXPERIMENTAL

Blood glucose control guided by the LOGIC-Insulin algorithm

Device: LOGIC-Insulin algorithm

Interventions

LOGIC-Insulin algorithm DEVICE

LOGIC-Insulin

Paper protocol DEVICE

Nurse-directed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead
• Agentschap voor Innovatie door Wetenschap en Technologie: collaborator

Study Sites (4)

Jessa Hospital

Hasselt, 3500, Belgium

Location

Dept Intensive Care Medicine, University Hospitals Leuven

Leuven, 3000, Belgium

Location

Medical Intensive Care, University Hospitals Leuven

Leuven, 3000, Belgium

Location

Academic Medical Center (AMC)

Amsterdam, 1105, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 22961576 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.

  PMID: 18302732 BACKGROUND

• 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.

  PMID: 19531590 BACKGROUND

• 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.

  PMID: 28806982 DERIVED

MeSH Terms

Conditions

Critical Illness; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dieter Mesotten, MD, PhD

  KU Leuven

  STUDY DIRECTOR

• Greet Van den Berghe, MD, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Jasperina Dubois, MD

  Jessa hospital, Hasselt

  PRINCIPAL INVESTIGATOR

• Marcus Schultz, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 6, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

NL (1); BE (3)