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

KU Leuven4 sites in 1 country9,230 target enrollmentSeptember 18, 2018

ConditionsCritical Illness Hyperglycemia

InterventionsInsulin

DrugsInsulin

Overview

Phase: Phase 3
Intervention: Insulin
Conditions: Critical Illness
Sponsor: KU Leuven
Enrollment: 9230
Locations: 4
Primary Endpoint: Duration of ICU dependency
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 18, 2018

End Date

November 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

KU Leuven

Responsible Party

Principal Investigator

Greet Van den Berghe

Full professor, Head of the clinical department and laboratory of intensive care medicine

KU Leuven

Eligibility Criteria

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

Arms & Interventions

Tight glucose control

Target normal fasting blood glucose concentrations (80-110 mg/dl) with insulin therapy, administered through continuous intravenous infusion.

Intervention: Insulin

Liberal glucose control

Tolerate hyperglycemia up to 215 mg/dl. In patients requiring insulin therapy, insulin will be titrated to target blood glucose concentrations between 180 and 215 mg/dl.

Intervention: Insulin

Outcomes

Primary Outcomes

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

Incidence of acute kidney injury in ICU(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Incidence of new infections in ICU(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Type of new infections in ICU(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Blood glucose concentrations in ICU(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Duration of antibiotic treatment in ICU(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Time to (live) weaning from hemodynamic support(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Rehabilitation/functional outcome(up to 2 years post randomization)
Survival(up to 4 years post randomization (in selected centers))
ICU Mortality(up to 1 year after randomization (with and without censoring at 90 days post randomization))
Time to (live) discharge from hospital(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Presence of clinical, electrophysiological and morphological signs of respiratory and peripheral muscle weakness in ICU(up to 1 year post randomization, with and without censoring at 90 days post randomization (in selected centers))
Hospital Mortality(up to 1 year after randomization (with and without censoring at 90 days post randomization))
Duration of ICU dependency(up to 90 days post randomization)
Length of stay in hospital(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Time course of daily C-reactive protein in ICU(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Time to final (live) weaning from mechanical respiratory support in ICU(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Number of participants with need for a tracheostomy during ICU stay(up to 1 year post randomization, with and without censoring at 90 days post randomization)
90-day mortality(up to 90 days post randomization)
Duration of acute kidney injury(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Duration of hemodynamic support in ICU(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Muscle strength(up to 4 years post randomization (in selected centers))
Rate of recovery from acute kidney injury(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Incidence of delirium in ICU (in selected centers)(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Number of participants with need for new renal replacement therapy in ICU(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Rate of recovery from new renal replacement therapy(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Number of participants with need for hemodynamic support in ICU(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Time course of markers of liver dysfunction in ICU(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Number of readmissions to the ICU within 48 hours after discharge(up to 1 year post randomization, with and without censoring at 90 days post randomization)
Rehabilitation/Functional outcome(up to 4 years post randomization (in selected centers))
Rate of recovery of organ function(up to 4 years post randomization (in selected centers))
Rehabilitation/functional outcome in patients with brain injury(up to 1 year post randomization)
Blood lipid concentrations in ICU(up to 4 years post randomization (in selected centers))
Use of intensive care resources during index hospitalization(up to 1 year post randomization)