Skip to main content
OpenTrials
Completed

NCT Number: NCT02056353

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critical Illness Disease Attributes Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Hospital, Hasselt, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LOGIC-Insulin algorithm

Device

Paper protocol

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie

Registry information

Official study title

LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-2 Multicentre Randomized Controlled Trial

Acronym: LOGIC-2

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2014
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.