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The effect of strict blood glucose control within normal fasting ranges, with insulin adjusted according to the Leuven algorithm, in adult critically ill patients.
EU CTIS ID: 2023-510358-17-00
What this study is testing
The purpose of the study is to investigate whether strictly targeting normal fasting ranges for blood glucose with use of a validated algorithm is clinically superior to tolerating hyperglycemia in adult critically ill patients in the context of withholding parenteral nutrition during the first week in the intensive care unit (ICU). The primary objective is to study the short-term clinical impact of the studied intervention (short-term morbidity and mortality).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- adult (≥18 years of age)
- admitted to one of the participating intensive care units
You likely can't join if
- Patients with a DNR (do not resuscitate) order at the time of ICU admission
- Patients with inborn metabolic diseases
- Patients with insulinoma
- Patients known to be pregnant or lactating
- Patients expected to die within 12 hours after ICU admission (= moribund patients)
- Patients able to receive oral feeding (not critically ill)
See the full eligibility criteria
- adult (≥18 years of age)
- admitted to one of the participating intensive care units
- Patients with a DNR (do not resuscitate) order at the time of ICU admission
- Patients with inborn metabolic diseases
- Patients with insulinoma
- Patients known to be pregnant or lactating
- 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)
- Inclusion in an IMP-RCT of which the PI indicates that co-inclusion specifically in TGC-fast 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.