Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients

Phase 3Active Not RecruitingNCT03665207

KU Leuven9,230 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

9,230

Conditions

Critical Illness Hyperglycemia

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Department of Intensive Care Medicine, University Hospital Ghent

Ghent, Belgium

Department of Intensive Care Medicine, Jessa Hospital Hasselt

Hasselt, Belgium

Department of Intensive Care Medicine, University Hospitals Leuven

Leuven, Belgium

Medical Intensive Care Unit, University Hospitals Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Duration of ICU dependency

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

Time frame: up to 1 year after randomization

Secondary Outcomes

ICU Mortality

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

Hospital Mortality

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

90-day mortality

Time frame: up to 90 days post randomization

Blood glucose concentrations in ICU