Impact of Tight blood Glucose Control within normal fasting ranges with insulin titration prescribed by the Leuven algorithm in adult critically ill patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000756-17-BE

Enrollment

9230

Registered

2018-03-07

Start date

2018-05-30

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia in critically ill patients (stress hyperglycemia) MedDRA version: 20.1 Level: LLT Classification code 10042216 Term: Stress induced hyperglycemia System Organ Class: 100000004861

Interventions

Product Name: Insulin Pharmaceutical Form: Concentrate for solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult (=18 years of age) patient admitted to one of the participating intensive care units Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4930

Exclusion criteria

Exclusion criteria: - Patients with a DNR (do not resuscitate) 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 already enrolled in another randomized controlled trial (RCT) powered for clinical endpoints - 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 - No informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of the study is to investigate whether strictly targeting normal fasting ranges for blood glucose with use of a validated algorithm is clinically superior to tolerating hyperglycemia in adult critically ill patients in the context of withholding parenteral nutrition during the first week in the intensive care unit (ICU). The primary objective is to study the short-term clinical impact of the studied intervention (short-term morbidity and mortality).;Secondary Objective: - To study the long-term impact of the intervention (morbidity and mortality) (partly depending on additional funding) - To study the economic impact (healthcare resources) - To study the pathophysiological mechanisms involved (depending on additional funding);Primary end point(s): The incidence of new infections during ICU stay and the duration of ICU dependency (defined as the crude number of days with need for vital organ support and as the time to live discharge from ICU to account for death as competing risk), with and without censoring at 90 days;Timepoint(s) of evaluation of this end point: - At the last day in ICU - At 90 days	—

Measure

Time frame

Main Objective: The purpose of the study is to investigate whether strictly targeting normal fasting ranges for blood glucose with use of a validated algorithm is clinically superior to tolerating hyperglycemia in adult critically ill patients in the context of withholding parenteral nutrition during the first week in the intensive care unit (ICU). The primary objective is to study the short-term clinical impact of the studied intervention (short-term morbidity and mortality).;Secondary Objective: - To study the long-term impact of the intervention (morbidity and mortality) (partly depending on additional funding) - To study the economic impact (healthcare resources) - To study the pathophysiological mechanisms involved (depending on additional funding);Primary end point(s): The incidence of new infections during ICU stay and the duration of ICU dependency (defined as the crude number of days with need for vital organ support and as the time to live discharge from ICU to account for death as competing risk), with and without censoring at 90 days;Timepoint(s) of evaluation of this end point: - At the last day in ICU - At 90 days

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Secondary

Measure	Time frame
Secondary end point(s): - Glucose metrics in ICU, with and without censoring at 90 days (mean/median morning blood glucose concentration, mean daily blood glucose concentration, incidence of moderate and severe hypoglycemia during ICU stay, peak blood glucose concentration after hypoglycemic event, duration of hypoglycemia, number of hypoglycemic events per patient, minimum and maximum blood glucose concentration per day, time within blood glucose target range, blood glucose variability, hyperglycemic index) - Mortality in ICU and in hospital, with and without censoring at 90 days - Mortality 90 days post randomization - Hospital length of stay, with and without censoring at 90 days - Time to (live) discharge from hospital, with and without censoring at 90 days - Time to final (live) weaning from mechanical respiratory support, with and without censoring at 90 days - The need for tracheostomy during ICU stay, with and without censoring at 90 days - Presence of clinical, electrophysiological and morphological signs of respiratory and peripheral muscle weakness during ICU stay in patient subgroups in selected centers, with and without censoring at 90 days - The presence or absence of new kidney injury during ICU stay, and duration and recovery herefrom, with and without censoring at 90 days - The need for new initiation of renal replacement therapy in ICU (incidence, duration and recovery hereof), with and without censoring at 90 days - The need for hemodynamic support during ICU stay, its duration and the time to (live) weaning from hemodynamic support, with and without censoring at 90 days - The presence or absence of signs of liver dysfunction in ICU, with and without censoring at 90 days - The duration of antibiotic treatment during ICU stay, with and without censoring at 90 days - The incidence of bacteremia, and of airway, urinary tract, wound and other infections acquired during ICU stay, with and without censoring at 90 days - Peak and time p	—

Measure

Time frame

Secondary end point(s): - Glucose metrics in ICU, with and without censoring at 90 days (mean/median morning blood glucose concentration, mean daily blood glucose concentration, incidence of moderate and severe hypoglycemia during ICU stay, peak blood glucose concentration after hypoglycemic event, duration of hypoglycemia, number of hypoglycemic events per patient, minimum and maximum blood glucose concentration per day, time within blood glucose target range, blood glucose variability, hyperglycemic index) - Mortality in ICU and in hospital, with and without censoring at 90 days - Mortality 90 days post randomization - Hospital length of stay, with and without censoring at 90 days - Time to (live) discharge from hospital, with and without censoring at 90 days - Time to final (live) weaning from mechanical respiratory support, with and without censoring at 90 days - The need for tracheostomy during ICU stay, with and without censoring at 90 days - Presence of clinical, electrophysiological and morphological signs of respiratory and peripheral muscle weakness during ICU stay in patient subgroups in selected centers, with and without censoring at 90 days - The presence or absence of new kidney injury during ICU stay, and duration and recovery herefrom, with and without censoring at 90 days - The need for new initiation of renal replacement therapy in ICU (incidence, duration and recovery hereof), with and without censoring at 90 days - The need for hemodynamic support during ICU stay, its duration and the time to (live) weaning from hemodynamic support, with and without censoring at 90 days - The presence or absence of signs of liver dysfunction in ICU, with and without censoring at 90 days - The duration of antibiotic treatment during ICU stay, with and without censoring at 90 days - The incidence of bacteremia, and of airway, urinary tract, wound and other infections acquired during ICU stay, with and without censoring at 90 days - Peak and time p

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Countries

Belgium

Contacts

Public ContactGreet Van den Berghe

KU Leuven

greet.vandenberghe@kuleuven.be+3216344021

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 13, 2026