Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients (TGC-fast)

Catholic University (KU) of Leuven

Status and phase: Active, not recruiting; Phase 3

Conditions: Hyperglycemia; Critical Illness

Treatments: Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03665207

S61145

2018-000756-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 9,230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9,230 participants in 2 patient groups

Tight glucose control

Experimental group

Description:

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

Treatment:

Drug: Insulin

Liberal glucose control

Active Comparator group

Description:

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.

Treatment:

Drug: Insulin