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

Primary Purpose

Critical Illness, Hyperglycemia, Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
LOGIC-Insulin algorithm
Paper protocol
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Software, Algorithm, Cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jessa Hospital
  • Dept Intensive Care Medicine, University Hospitals Leuven
  • Medical Intensive Care, University Hospitals Leuven
  • Academic Medical Center (AMC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nurse-directed

LOGIC-Insulin

Arm Description

Blood glucose control guided by paper protocol

Blood glucose control guided by the LOGIC-Insulin algorithm

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
Blood Glucose Level Per Treatment Group during the Intervention
Mean and median arterial blood glucose level
Hyperglycaemic index (HGI)
Adequacy of reaching and maintaining the target range for blood glucose, as assessed by the Hyperglycaemic index (HGI)
Time in target range
Time to target range
Daily maximal blood glucose difference
marker of blood glucose fluctuations
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
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
Interval between blood glucose measurements
marker of workload
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.
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
Incidence of new infections in the ICU
The diagnosis of "new infection" will be based on the administration of antibiotics, beyond the prophylactic scope
Length of stay in the ICU
Length of stay in the hospital
Mortality in the ICU
Mortality in the hospital
Landmark 90-day mortality
All direct medical costs from a healthcare payer's perspective
Quality of Life
EuroQol-5D

Full Information

First Posted
February 4, 2014
Last Updated
January 7, 2016
Sponsor
KU Leuven
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie
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1. Study Identification

Unique Protocol Identification Number
NCT02056353
Brief Title
Multicentre LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (LOGIC-2)
Acronym
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Hyperglycemia, Hypoglycemia
Keywords
Software, Algorithm, Cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1550 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse-directed
Arm Type
Active Comparator
Arm Description
Blood glucose control guided by paper protocol
Arm Title
LOGIC-Insulin
Arm Type
Experimental
Arm Description
Blood glucose control guided by the LOGIC-Insulin algorithm
Intervention Type
Device
Intervention Name(s)
LOGIC-Insulin algorithm
Intervention Type
Device
Intervention Name(s)
Paper protocol
Primary Outcome Measure Information:
Title
Glycemic Penalty Index (GPI) during the Intervention
Description
Adequacy of reaching and maintaining the target range for blood glucose during the intervention (Effectiveness of glycaemic control)
Time Frame
up to 14 days post-randomization
Secondary Outcome Measure Information:
Title
Proportion of Patients With Severe Hypoglycaemia (<40 mg/dL) during the Intervention
Description
Proportion of patients to have had one or more episodes of severe hypoglycaemia (<40 mg/dL) during the intervention
Time Frame
up to 14 days post-randomization
Title
Incidence of Severe Hypoglycemia (<40 mg/dL) during the Intervention
Description
Number of severe hypoglycaemic values as a fraction of all blood glucose measurements during the intervention
Time Frame
up to 14 days post-randomization
Title
Blood Glucose Level Per Treatment Group during the Intervention
Description
Mean and median arterial blood glucose level
Time Frame
up to 14 days post-randomization
Title
Hyperglycaemic index (HGI)
Description
Adequacy of reaching and maintaining the target range for blood glucose, as assessed by the Hyperglycaemic index (HGI)
Time Frame
up to 14 days post-randomization
Title
Time in target range
Time Frame
up to 14 days post-randomization
Title
Time to target range
Time Frame
up to 14 days post-randomization
Title
Daily maximal blood glucose difference
Description
marker of blood glucose fluctuations
Time Frame
up to 14 days post-randomization
Title
Incidence of mild hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention
Description
Number of mild hypoglycaemic values as a fraction of all blood glucose measurements during the intervention
Time Frame
up to 14 days post-randomization
Title
Proportion of Patients With Mild Hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention
Description
Proportion of patients to have had one or more episodes of mild hypoglycaemia during the intervention
Time Frame
up to 14 days post-randomization
Title
Interval between blood glucose measurements
Description
marker of workload
Time Frame
up to 14 days post-randomization
Title
Protocol compliance in the intervention group
Description
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.
Time Frame
up to 14 days post-randomization
Title
Overrules in the intervention group
Description
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
Time Frame
up to 14 days post-randomization
Title
Incidence of new infections in the ICU
Description
The diagnosis of "new infection" will be based on the administration of antibiotics, beyond the prophylactic scope
Time Frame
up to 90 days post-randomization
Title
Length of stay in the ICU
Time Frame
up to 90 days post-randomization
Title
Length of stay in the hospital
Time Frame
up to 90 days post-randomization
Title
Mortality in the ICU
Time Frame
up to 90 days post-randomization
Title
Mortality in the hospital
Time Frame
up to 90 days post-randomization
Title
Landmark 90-day mortality
Time Frame
up to 90 days post-randomization
Title
All direct medical costs from a healthcare payer's perspective
Time Frame
up to 90 days post-randomization
Title
Quality of Life
Description
EuroQol-5D
Time Frame
up to 90 days post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Mesotten, MD, PhD
Organizational Affiliation
KU Leuven
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Greet Van den Berghe, MD, PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jasperina Dubois, MD
Organizational Affiliation
Jessa hospital, Hasselt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcus Schultz, MD, PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Dept Intensive Care Medicine, University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Medical Intensive Care, University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Academic Medical Center (AMC)
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22961576
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.
Results Reference
background
PubMed Identifier
18302732
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.
Results Reference
background
PubMed Identifier
19531590
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.
Results Reference
background
PubMed Identifier
28806982
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.
Results Reference
derived

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

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