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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056353
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : January 8, 2016
Sponsor:
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
Greet Van den Berghe, KU Leuven

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.

Condition or disease Intervention/treatment Phase
Critical Illness Hyperglycemia Hypoglycemia Device: LOGIC-Insulin algorithm Device: Paper protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nurse-directed
Blood glucose control guided by paper protocol
Device: Paper protocol
Experimental: LOGIC-Insulin
Blood glucose control guided by the LOGIC-Insulin algorithm
Device: LOGIC-Insulin algorithm



Primary Outcome Measures :
  1. Glycemic Penalty Index (GPI) during the Intervention [ Time Frame: up to 14 days post-randomization ]
    Adequacy of reaching and maintaining the target range for blood glucose during the intervention (Effectiveness of glycaemic control)


Secondary Outcome Measures :
  1. Proportion of Patients With Severe Hypoglycaemia (<40 mg/dL) during the Intervention [ Time Frame: up to 14 days post-randomization ]
    Proportion of patients to have had one or more episodes of severe hypoglycaemia (<40 mg/dL) during the intervention

  2. Incidence of Severe Hypoglycemia (<40 mg/dL) during the Intervention [ Time Frame: up to 14 days post-randomization ]
    Number of severe hypoglycaemic values as a fraction of all blood glucose measurements during the intervention

  3. Blood Glucose Level Per Treatment Group during the Intervention [ Time Frame: up to 14 days post-randomization ]
    Mean and median arterial blood glucose level

  4. Hyperglycaemic index (HGI) [ Time Frame: up to 14 days post-randomization ]
    Adequacy of reaching and maintaining the target range for blood glucose, as assessed by the Hyperglycaemic index (HGI)

  5. Time in target range [ Time Frame: up to 14 days post-randomization ]
  6. Time to target range [ Time Frame: up to 14 days post-randomization ]
  7. Daily maximal blood glucose difference [ Time Frame: up to 14 days post-randomization ]
    marker of blood glucose fluctuations

  8. Incidence of mild hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention [ Time Frame: up to 14 days post-randomization ]
    Number of mild hypoglycaemic values as a fraction of all blood glucose measurements during the intervention

  9. Proportion of Patients With Mild Hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention [ Time Frame: up to 14 days post-randomization ]
    Proportion of patients to have had one or more episodes of mild hypoglycaemia during the intervention

  10. Interval between blood glucose measurements [ Time Frame: up to 14 days post-randomization ]
    marker of workload

  11. Protocol compliance in the intervention group [ Time Frame: up to 14 days post-randomization ]
    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.

  12. Overrules in the intervention group [ Time Frame: up to 14 days post-randomization ]

    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

  13. Incidence of new infections in the ICU [ Time Frame: up to 90 days post-randomization ]
    The diagnosis of "new infection" will be based on the administration of antibiotics, beyond the prophylactic scope

  14. Length of stay in the ICU [ Time Frame: up to 90 days post-randomization ]
  15. Length of stay in the hospital [ Time Frame: up to 90 days post-randomization ]
  16. Mortality in the ICU [ Time Frame: up to 90 days post-randomization ]
  17. Mortality in the hospital [ Time Frame: up to 90 days post-randomization ]
  18. Landmark 90-day mortality [ Time Frame: up to 90 days post-randomization ]
  19. All direct medical costs from a healthcare payer's perspective [ Time Frame: up to 90 days post-randomization ]
  20. Quality of Life [ Time Frame: up to 90 days post-randomization ]
    EuroQol-5D



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056353


Locations
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Belgium
Jessa Hospital
Hasselt, Belgium, 3500
Dept Intensive Care Medicine, University Hospitals Leuven
Leuven, Belgium, 3000
Medical Intensive Care, University Hospitals Leuven
Leuven, Belgium, 3000
Netherlands
Academic Medical Center (AMC)
Amsterdam, Netherlands, 1105
Sponsors and Collaborators
KU Leuven
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
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Study Director: Dieter Mesotten, MD, PhD KU Leuven
Principal Investigator: 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)
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Greet Van den Berghe, Prof. Dr., KU Leuven
ClinicalTrials.gov Identifier: NCT02056353    
Other Study ID Numbers: LOGIC-Insulin 2.1.1
ML9517 ( Other Identifier: IRB-BE )
S55613 ( Other Identifier: University Hospitals Leuven )
80M0563 ( Other Identifier: FAMHP )
IWT-TBM 100793 ( Other Grant/Funding Number: IWT-TBM )
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Keywords provided by Greet Van den Berghe, KU Leuven:
Software
Algorithm
Cardiac surgery
Additional relevant MeSH terms:
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Hypoglycemia
Hyperglycemia
Critical Illness
Glucose Metabolism Disorders
Metabolic Diseases
Disease Attributes
Pathologic Processes
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs