Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KU Leuven
• Collaborators: Research Foundation Flanders; Universitaire Ziekenhuizen Leuven
• Treatments: Insulin

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

• Patients with insulinoma

• Patients known to be pregnant or lactating

• Informed consent refusal