RecruitingACTRN12621000859886

REDuced CARBohydrate enteral formula compared to standard care in hyperglycaemic critically ill tube fed patients – a randomised controlled phase II trial

REDuced CARBohydrate enteral formula compared to standard care to improve glycaemic control in critically ill tube fed patients – a randomised controlled phase II trial


Sponsor

The University of Queensland

Enrollment

160 participants

Start Date

Feb 15, 2022

Study Type

Interventional

Conditions

Summary

A prospective randomised controlled pilot trial investigating the effectiveness of a reduced carbohydrate enteral formula in improving clinically important surrogate markers (reduced insulin administration, glycaemic variability and hypoglycaemic episodes) associated with increased mortality in hyperglycaemic critically ill enterally fed patients when compared to standard care Aims: To determine if the use of a reduced carbohydrate formula improves overall blood glucose control and clinical outcomes when compared to standard care in critically ill patients with hyperglycaemia. Hypothesis: Patients receiving a reduced carbohydrate formula will have improved glycaemic control during their ICU admission when compared to patients receiving standard care.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether using a specially formulated tube feed with reduced carbohydrate content can improve blood sugar control in critically ill patients who are receiving nutrition through a tube (enteral nutrition) and who have developed high blood sugar levels (hyperglycaemia) in the ICU. High blood sugar is very common in critically ill patients and is linked to worse outcomes, including a higher risk of death. Participants in the intensive care unit who need tube feeding and have recently had blood sugar levels above 10 mmol/L or required insulin will be randomly assigned to receive either the reduced-carbohydrate formula or standard tube feed formula. Researchers will track blood glucose levels, insulin requirements, and other clinical outcomes during their ICU stay. To be eligible, you must be an adult (18 or older) admitted to an ICU, currently receiving or about to start enteral (tube) feeding, and have had recent high blood sugar levels or required insulin for glucose control. Patients who have already been tube-fed for more than 72 hours or who have a very poor prognosis are not eligible. This pilot trial is run by The University of Queensland.

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

• The intervention EN formula, a reduced carbohydrate formula (Glucerna Select®) will be commenced, with a target rate which is calorically equivalent to the amount that was being provided or targeted

• The intervention EN formula, a reduced carbohydrate formula (Glucerna Select®) will be commenced, with a target rate which is calorically equivalent to the amount that was being provided or targeted while the patient received routine clinical care. • All other aspects of nutrition and blood glucose management (e.g. gastric residual volume management, prokinetic use, cessation for procedures, insulin dose) remain as per routine clinical practice. • Intervention formula use will continue for the duration enteral feeding is clinically required in ICU. • Medical records will be used to assess to nutrition delivery, glycaemic control and clinical outcome measures


Locations(8)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

Mater Adult Hospital - South Brisbane

QLD, Australia

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

The Prince Charles Hospital - Chermside

QLD, Australia

Logan Hospital - Meadowbrook

QLD, Australia

Redcliffe Hospital - Redcliffe

QLD, Australia

Caboolture Hospital - Caboolture

QLD, Australia

Ipswich Hospital - Ipswich

QLD, Australia

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ACTRN12621000859886


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