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

Not Applicable

Recruiting

• Conditions: Hyperglycaemia; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12621000859886
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-02
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nits of insulin administered as per daily ICU records[ Daily, to a maximum of 7 days post randomisation]