Study of Insulin Treatment for Blood Glucose Control in Adult Critically Ill Patients with Stress Hyperglycemia

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What is this study about?

This study focuses on managing hyperglycemia (high blood sugar) in critically ill patients who are being treated in the intensive care unit (ICU). The condition being studied is known as stress hyperglycemia, which often occurs in severely ill patients even if they have not previously had diabetes. The treatment being tested involves the use of human insulin to strictly control blood sugar levels within normal fasting ranges.

The purpose of this research is to determine if keeping blood sugar levels tightly controlled within normal ranges using a specific dosing plan (called the Leuven algorithm) leads to better outcomes compared to allowing higher blood sugar levels in critically ill adult patients. During the study, patients will receive insulin through an intravenous line, with doses adjusted according to their blood sugar measurements.

The study will monitor how the treatment affects patients’ recovery during their ICU stay. This includes tracking how long patients need intensive care support, checking for complications, and following their overall progress. The maximum daily dose of insulin that may be given is 1,200 international units, and patients may receive treatment for up to 12 months if needed.

1 Initial admission

Upon admission to the intensive care unit (ICU), your blood glucose levels will be monitored.

You will receive insulin through an intravenous line to control blood sugar levels within normal fasting ranges.

2 Daily monitoring

Your blood glucose levels will be checked regularly, particularly in the morning.

The insulin dose will be adjusted according to a specific algorithm to maintain proper blood sugar control.

Your vital organ functions will be continuously monitored throughout your ICU stay.

3 Hospital stay monitoring

Your overall health status will be monitored, including heart function, kidney function, and potential infections.

Regular assessments will track your progress and any complications that may develop.

The medical team will monitor your need for breathing support and other medical interventions.

4 Follow-up period

After 90 days, there will be an assessment of your recovery progress.

At 2 years after joining the study, you will complete a health questionnaire about your general well-being.

Additional health checks may continue for up to 5 years, focusing on long-term recovery and organ function.

Who Can Join the Study?

You must be at least 18 years old to participate in the study
You must be currently admitted to one of the participating intensive care units (specialized hospital departments that provide intensive monitoring and treatment for critically ill patients)
You may be either male or female to participate
You must have high blood sugar levels while being critically ill (a condition known as stress hyperglycemia)
You must be receiving care in the intensive care unit (ICU)
You must be willing to have your blood sugar levels monitored and managed according to the study protocol
You must not be receiving parenteral nutrition (nutrition given through a vein) during your first week in the ICU

Who Cannot Join the Study?

Age under 18 years or over 80 years
Pregnant women or nursing mothers
Patients with pre-existing diabetes (a condition where body cannot properly control blood sugar levels)
Patients receiving parenteral nutrition (nutrition delivered through veins) before ICU admission
Patients with known allergies to insulin or other study medications
Patients with severe liver disease or kidney failure requiring dialysis
Patients with terminal illness with life expectancy less than 7 days
Patients who cannot provide informed consent or have no legally authorized representative
Patients participating in other clinical trials
Patients with conditions that might interfere with blood glucose measurements
Patients with hypoglycemia (very low blood sugar) at admission
Patients with burns covering more than 20% of body surface

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country	Status
Jessa Ziekenhuis	Hasselt	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.09.2018

Trial locations

Investigated drugs:

Insulin Human

Insulin
This is a medication that helps control blood sugar levels in the body. In this trial, it is used to maintain tight blood glucose control within normal fasting ranges in critically ill patients in intensive care. The insulin is adjusted using a specific protocol (Leuven algorithm) to achieve target blood sugar levels.

Parenteral Nutrition
This is a method of providing nutrition directly into the bloodstream through an intravenous (IV) line. In this trial, patients will not receive parenteral nutrition during their first week in intensive care, as researchers study how this approach combined with insulin therapy affects patient outcomes.

Stress Hyperglycemia – A temporary rise in blood glucose levels that occurs during severe illness or critical medical conditions. This condition develops when the body releases stress hormones in response to severe physical stress, leading to increased glucose production by the liver and insulin resistance in tissues. Stress hyperglycemia typically appears in critically ill patients, even those without a previous history of diabetes. The condition causes elevated blood sugar levels above normal ranges, particularly during fasting periods. It is a distinct condition from regular diabetes, as it typically resolves once the underlying stress or illness improves.

Trial ID:

2023-510358-17-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Insulin Treatment for Blood Glucose Control in Adult Critically Ill Patients with Stress Hyperglycemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?