RecruitingACTRN12611001261909

Stochastic Targeted Glycemic Control in the Intensive Care Unit Pilot Trials

Insulin and Nutrition Dosing Using a Stochastic Targeting Model-Based System for Improved Control of Blood Glucose Levels in Intensive Care Patients


Sponsor

Dr Geoffrey M Shaw

Enrollment

30 participants

Start Date

Jan 11, 2011

Study Type

Interventional

Conditions

Summary

Critically ill patients often experience stress-induced hyperglycaemia (high blood sugar levels) and insulin resistance, resulting in increased infection, cardiac events and death. The Christchurch ICU currently controls glucose levels using a system called SPRINT, a paper-based protocol that has provided world leading control and reduced mortality 25-40% in patients who stay 3 days or longer in the ICU. It has also reduced costs by over $1000 per patient treated. However, SPRINT does not allow clinicians to make changes or provide more patient-specific care, when necessary. STAR is a system that uses an algorithm and computer model to provide equivalent or tighter control of glucose levels with greater clinical flexibility and less nursing effort through reduced need for measurements or/and intervention. It also improves safety from low glucose levels (hypoglycaemia) using a statistical model to provide a guaranteed risk of hypoglycemia of 0.1%. STAR pilot trials will be supervised by medical personnel and run for as long as a patient requires glycemic control during their ICU stay. Target glycemic levels will be chosen by the clinical staff. The algorithm will determine all insulin doses and enteral nutrition given to achieve that target with guaranteed safety from hypoglycemia.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a computerised system called STAR (Stochastic TARgeted glycemic control) that helps doctors manage blood sugar levels in critically ill ICU patients. High blood sugar is very common in ICU patients and increases the risk of complications and death. STAR uses a computer model and algorithm to calculate exactly how much insulin to give, keeping blood sugar in a safe range while also reducing the risk of dangerously low blood sugar (hypoglycaemia). You may be eligible if: - You are 16 years or older - You are a patient in the Intensive Care Unit - Your blood glucose is above 8 mmol/L - You have an arterial line in place You may NOT be eligible if: - You are not expected to survive more than 72 hours - You do not have an arterial line Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

STAR is a system that uses an algorithm and computer model to provide equivalent or tighter control of glucose levels. Target glycemic levels will be chosen by the clinical staff dependent on patient

STAR is a system that uses an algorithm and computer model to provide equivalent or tighter control of glucose levels. Target glycemic levels will be chosen by the clinical staff dependent on patient characteristics, the most common target range is 4.4-8.0 mmol/L. The algorithm will determine all insulin doses and enteral nutrition given to achieve that target with safety from hypoglycemia. STAR clinical trials will run until 30 June 2012 and will occur whenever there is an eligible patient in the ICU from whom consent has been obtained.


Locations(1)

Christchurch, New Zealand

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ACTRN12611001261909