Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients
- Registration Number
- NCT03665207
- Lead Sponsor
- KU Leuven
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 9230
- Adult patient (18 years or older) admitted to a participating intensive care unit (ICU)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tight glucose control Insulin Target normal fasting blood glucose concentrations (80-110 mg/dl) with insulin therapy, administered through continuous intravenous infusion. Liberal glucose control Insulin 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.
- Primary Outcome Measures
Name Time Method Duration of ICU dependency up to 1 year after randomization crude number of days with need for vital organ support and time to live discharge from ICU
- Secondary Outcome Measures
Name Time Method 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 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.
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 crude number of days with need for vital organ support and time to live discharge from ICU
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) including handgrip strength as % of the predicted value
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 Hemodynamic support is defined as the need for either pharmacological (inotropes/vasopressors) and/or mechanical hemodynamic support.
Time course of markers of liver dysfunction in ICU up to 1 year post randomization, with and without censoring at 90 days post randomization including transaminases, gamma-glutamyltransferase, alkaline phosphatase and bilirubin
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) including the score obtained from the SF-36 health survey. The score ranges from 0 to 100, with 100 being the best possible outcome.
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 including the score obtained on the extended Glasgow outcome scale. The score ranges from 1 to 8, with 8 being the best possible outcome.
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
Trial Locations
- Locations (4)
Medical Intensive Care Unit, University Hospitals Leuven
🇧🇪Leuven, Belgium
Department of Intensive Care Medicine, Jessa Hospital Hasselt
🇧🇪Hasselt, Belgium
Department of Intensive Care Medicine, University Hospitals Leuven
🇧🇪Leuven, Belgium
Department of Intensive Care Medicine, University Hospital Ghent
🇧🇪Ghent, Belgium