RecruitingACTRN12614000166673

Diabetes specific formulae versus standard formulae as enteral nutrition to treat hyperglycaemia in critically ill patients: study protocol for a randomised controlled feasibility trial

A randomised controlled feasibility trial to determine the efficacy of diabetes specific formulae to reduce exogenous insulin doses required to obtain acceptable glycaemic control when compared to the standard nutritional formula in critically ill tube fed patients

Sponsor

Mater Foundation and Mater Research Institute

Enrollment

54 participants

Start Date

Jan 30, 2015

Study Type

Interventional

Conditions

Critically ill tube fed ICU patients Hyperglycemia

Summary

This is a prospective, blinded, randomised controlled feasibility trial of critically ill tube fed ICU patients looking at the effectiveness of diabetes specific nutritional formula in managing stress hyperglycaemia. The primary aim of this study is to determine whether the administration of a diabetes specific formula, when compared to standard enteral formula, reduces insulin use over a 48 hour period. Secondary outcomes include both clinical endpoints and assessment of the feasibility of study processes to inform a potential multi-site RCT. A sub-study will also be incorporated to determine if altered carbohydrate, is associated with a change in oxidative stress markers, as well acute and chronic inflammatory biomarkers.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

A patient is receiving exclusive enteral nutrition and requires an insulin infusion. Patients with two consecutive blood glucose levels > 10mmol/L are likely to commence on an insulin infusion based on the units’ glucose management protocol.

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Interventions

Following consent participants will be randomised to the control (CHO 142g/L; 1.28kcal/mL), or the intervention, which is a low carbohydrate, low glycaemic index diabetes-specific formula (CHO 75g/L;

Following consent participants will be randomised to the control (CHO 142g/L; 1.28kcal/mL), or the intervention, which is a low carbohydrate, low glycaemic index diabetes-specific formula (CHO 75g/L; 1kcal/mL), Once treatment allocation has occurred, participants will remain on treatment as long as tube feeding continues in ICU or as per the treating physician. All investigators and the participant will be blinded to treatment allocation. Nutritional requirements will be calculated by providing an average of 100-125kJ/kg body weight or adjusted ideal body weight (BW / AIBW) and 1.2-1.5g protein/kg BW/AIBW as per current practice. For the purpose of a biomarker sub-study, a second intervention arm using a different low glycaemic index diabetes specific formula will be used (CHO 113g/L; 1kcal/mL). Randomisation to this arm will be ceased once blood and urine samples are available for the first 10-12 participants in each group. These samples will be collected from all patients at randomisation and 48 hours later. Once this has been achieved, randomisation will revert to control and intervention groups only. Collection of urine and blood samples for biomarker assay will also be discontinued at this point.