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Active, Not Recruiting

NCT Number: NCT03665207

Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients

Critically ill patients usually develop hyperglycemia, which is associated with an increased risk of morbidity and mortality. Controversy exists on whether targeting normal blood glucose concentrations with insulin therapy, referred to as tight blood glucose control (TGC) improves outcome of these patients, as compared to tolerating hyperglycemia. It remains unknown whether TGC, when applied with optimal tools to avoid hypoglycemia, is beneficial in a context of withholding early parenteral nutrition. The TGC-fast study hypothesizes that TGC is beneficial in adult critically ill patients not receiving early parenteral nutrition, as compared to tolerating hyperglycemia.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Critical Illness Disease Attributes Glucose Metabolism Disorders Hyperglycemia 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

Phase 3

Primary location

Department of Intensive Care Medicine, University Hospital Ghent, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient (18 years or older) admitted to a participating intensive care unit (ICU)

Exclusion criteria

  • Patients with a do not resuscitate (DNR) order at the time of ICU admission
  • Patients expected to die within 12 hours after ICU admission (= moribund patients)
  • Patients able to receive oral feeding (not critically ill)
  • Patients without arterial and without central venous line and without imminent need to place it as part of ICU management (not critically ill)
  • Patients previously included in the trial (when readmission is within 48 hours post ICU discharge, the trial intervention will be resumed)
  • Patients included in an IMP-RCT of which the PI indicates that co-inclusion is prohibited
  • Patients transferred from a non-participating ICU with a pre-admission ICU stay >7 days
  • Patients planned to receive parenteral nutrition during the first week in ICU
  • Patients suffering from diabetic ketoacidotic or hyperosmolar coma on ICU admission
  • Patients with inborn metabolic diseases
  • Patients with insulinoma
  • Patients known to be pregnant or lactating
  • Informed consent refusal

Treatment and study plan

Insulin

Drug

When blood glucose exceeds the preset target, insulin will be administered through continuous intravenous infusion. Insulin will be titrated according to frequent measurement of blood glucose and with use of the LOGIC-insulin algorithm in the experimental group. The intervention will be stopped upon ICU discharge, or until the patient is able to resume oral feeding, or until the patient no longer has a central venous catheter, whatever comes first.

Primary outcomes

  1. Duration of ICU dependency

    Time frame: up to 1 year after randomization

    crude number of days with need for vital organ support and time to live discharge from ICU

Secondary outcomes

  1. ICU Mortality

    Time frame: up to 1 year after randomization (with and without censoring at 90 days post randomization)

  2. Hospital Mortality

    Time frame: up to 1 year after randomization (with and without censoring at 90 days post randomization)

  3. 90-day mortality

    Time frame: up to 90 days post randomization

  4. Blood glucose concentrations in ICU

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  5. Duration of ICU dependency

    Time frame: up to 90 days post randomization

    crude number of days with need for vital organ support and time to live discharge from ICU

  6. Length of stay in hospital

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  7. Time to (live) discharge from hospital

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  8. Incidence of new infections in ICU

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  9. Type of new infections in ICU

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  10. Duration of antibiotic treatment in ICU

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  11. Time course of daily C-reactive protein in ICU

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  12. Time to final (live) weaning from mechanical respiratory support in ICU

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  13. Number of participants with need for a tracheostomy during ICU stay

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  14. Presence of clinical, electrophysiological and morphological signs of respiratory and peripheral muscle weakness in ICU

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization (in selected centers)

  15. Incidence of acute kidney injury in ICU

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  16. Duration of acute kidney injury

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  17. Rate of recovery from acute kidney injury

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  18. Number of participants with need for new renal replacement therapy in ICU

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  19. Rate of recovery from new renal replacement therapy

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  20. Number of participants with need for hemodynamic support in ICU

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

    Hemodynamic support is defined as the need for either pharmacological (inotropes/vasopressors) and/or mechanical hemodynamic support.

  21. Duration of hemodynamic support in ICU

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  22. Time to (live) weaning from hemodynamic support

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  23. Time course of markers of liver dysfunction in ICU

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

    including transaminases, gamma-glutamyltransferase, alkaline phosphatase and bilirubin

  24. Number of readmissions to the ICU within 48 hours after discharge

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  25. Incidence of delirium in ICU (in selected centers)

    Time frame: up to 1 year post randomization, with and without censoring at 90 days post randomization

  26. Rehabilitation/functional outcome

    Time frame: up to 2 years post randomization

    including the score obtained from the 36-item short form health survey (SF-36). The score ranges from 0 to 100, with 100 being the best possible outcome.

  27. Rehabilitation/functional outcome in patients with brain injury

    Time frame: up to 1 year post randomization

    including the score obtained on the modified Rankin scale. The score ranges from 0 to 6, with 0 being the best possible outcome.

  28. Rehabilitation/functional outcome in patients with brain injury

    Time frame: up to 1 year post randomization

    including the score obtained on the extended Glasgow outcome scale. The score ranges from 1 to 8, with 8 being the best possible outcome.

  29. Blood lipid concentrations in ICU

    Time frame: up to 4 years post randomization (in selected centers)

  30. Muscle strength

    Time frame: up to 4 years post randomization (in selected centers)

    including handgrip strength as % of the predicted value

  31. Rehabilitation/Functional outcome

    Time frame: up to 4 years post randomization (in selected centers)

    including the 6-minutes walking distance in meter

  32. Rehabilitation/Functional outcome

    Time frame: up to 4 years post randomization (in selected centers)

    including the score obtained from the SF-36 health survey. The score ranges from 0 to 100, with 100 being the best possible outcome.

  33. Rate of recovery of organ function

    Time frame: up to 4 years post randomization (in selected centers)

  34. Survival

    Time frame: up to 4 years post randomization (in selected centers)

  35. Use of intensive care resources during index hospitalization

    Time frame: up to 1 year post randomization

Other outcomes

  1. Biochemical markers on blood samples

    Time frame: up to 4 years post randomization

    including amino acid levels, blood lipid levels, cytokines, hypothalamic-pituitary hormones, glucagon, C-peptide, (epi)genetic markers

  2. Rate of patients with muscle degeneration during ICU stay

    Time frame: up to 30 days post randomization (in selected centers)

    assessed by microscopy

  3. Biochemical markers in muscle tissue during ICU stay

    Time frame: up to 30 days post randomization (in selected centers)

    including tissular glucose and metabolites, lipid metabolites, myofibrillary proteins, mitochondrial complex activity, autophagy markers, proteasome activity, (epi)genetic markers

  4. Rate of patients with pathological cellular alterations in fat tissue during ICU stay

    Time frame: up to 30 days post randomization (in selected centers)

    assessed by microscopy

  5. Biochemical markers in fat tissue during ICU stay

    Time frame: up to 30 days post randomization (in selected centers)

    including tissular glucose and metabolites, lipid metabolites, mitochondrial complex activity, autophagy markers, (epi)genetic markers

  6. Rate of patients with muscle degeneration

    Time frame: up to 4 years post randomization (in selected centers)

    assessed by microscopy

  7. Biochemical markers in muscle tissue

    Time frame: up to 4 years post randomization (in selected centers)

    including tissular glucose and metabolites, lipid metabolites, myofibrillary proteins, mitochondrial complex activity, autophagy markers, proteasome activity, (epi)genetic markers

  8. Rate of patients with pathological cellular alterations in fat tissue

    Time frame: up to 4 years post randomization (in selected centers)

    assessed by microscopy

  9. Biochemical markers in fat tissue

    Time frame: up to 4 years post randomization (in selected centers)

    including tissular glucose and metabolites, lipid metabolites, mitochondrial complex activity, autophagy markers, (epi)genetic markers

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Research Foundation Flanders
  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

Impact of Tight Blood Glucose Control Within Normal Fasting Ranges With Insulin Titration Prescribed by the Leuven Algorithm in Adult Critically Ill Patients

Acronym: TGC-fast

Important dates

Study start
2018
Primary completion
2022
Study completion
2026
First posted
Sep 11, 2018
Registry last updated
Jun 5, 2023

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.

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