None listed
Conditions
Brief 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.
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 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
• 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
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Admission to ICU • Aged =18 years old • Receiving or able to receive enteral nutrition within the next 24 hours • In the last 24 hours, has received insulin for glycaemic control as per local protocol OR has had two consecutive blood glucose levels > 10mmol/L • EN remains indicated and is expected to continue until at least the day after tomorrow
Exclusion criteria
• Patient has been enterally fed for =72hrs during this admission episode • Treating clinician deems study formula to be clinically contraindicated • Patient expected to receive parenteral nutrition (total or supplemental) • Futility of care or death was imminent • Patient unlikely to regain capacity to consent and patient has no surrogate decision maker • Previously enrolled in REDCARB study or co-enrolment in other nutrition or glycaemic management intervention studies
Outcome results
None listed