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

NCT ID: NCT02056353

Last Updated: 2016-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Critical Illness Hyperglycemia Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Nurse-directed

Blood glucose control guided by paper protocol

Group Type ACTIVE_COMPARATOR

Paper protocol

Intervention Type DEVICE

LOGIC-Insulin

Blood glucose control guided by the LOGIC-Insulin algorithm

Group Type EXPERIMENTAL

LOGIC-Insulin algorithm

Intervention Type DEVICE

Interventions

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LOGIC-Insulin algorithm

Intervention Type DEVICE

Paper protocol

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agentschap voor Innovatie door Wetenschap en Technologie

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Greet Van den Berghe

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dieter Mesotten, MD, PhD

Role: STUDY_DIRECTOR

KU Leuven

Greet Van den Berghe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Jasperina Dubois, MD

Role: PRINCIPAL_INVESTIGATOR

Jessa hospital, Hasselt

Marcus Schultz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Jessa Hospital

Hasselt, , Belgium

Site Status

Dept Intensive Care Medicine, University Hospitals Leuven

Leuven, , Belgium

Site Status

Medical Intensive Care, University Hospitals Leuven

Leuven, , Belgium

Site Status

Academic Medical Center (AMC)

Amsterdam, , Netherlands

Site Status

Countries

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Belgium Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 22961576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18302732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19531590 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28806982 (View on PubMed)

Other Identifiers

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ML9517

Identifier Type: OTHER

Identifier Source: secondary_id

S55613

Identifier Type: OTHER

Identifier Source: secondary_id

80M0563

Identifier Type: OTHER

Identifier Source: secondary_id

IWT-TBM 100793

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

LOGIC-Insulin 2.1.1

Identifier Type: -

Identifier Source: org_study_id

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