BACKGROUND: Critically ill patients often experience dysglycaemia which is strongly associated with increased morbidity and mortality. While exogenous insulin therapy is used to manage hyperglycaemia, it has been demonstrated to increase the frequency of hypoglycaemic episodes and variability in blood glucose, both of which have been shown to increase mortality. Enteral feeding may worsen glycaemic control due to its carbohydrate content. This study aims to determine if the use of a reduced carbohydrate formula improves overall glycaemic control when compared to standard care in critically ill patients with hyperglycaemia.
METHODS: This is the protocol for a multicentre, prospective randomised controlled trial conducted at 7 intensive care units (ICU). One hundred and sixty patients admitted to ICU, receiving or about to receive enteral nutrition expected to continue until the day after tomorrow, who have had two consecutive blood glucose levels >10 mmol/L or have received insulin based on local protocols within the previous 24-h period, and who meet none of the exclusion criteria, will be eligible. Patients in the standard care arm will receive enteral nutrition as per usual site practice and patients in the intervention arm will receive Glucerna Select® to achieve a caloric equivalent to that prescribed or delivered prior to study recruitment. All other aspects of nutrition management remain as per routine clinical practice. The primary outcome measure is units of insulin administered per day in the ICU to a maximum of seven days post randomisation. Key secondary outcome measures include measures of glycaemic control, nutrition provision, nutrition tolerance and clinical outcomes such as infectious complications, duration of ventilation, ICU and hospital stay as well as in hospital mortality.
DISCUSSION: This study will provide data on whether the use of a reduced carbohydrate enteral nutrition formula reduces insulin administration thereby improving dysglycaemia in critically ill patients. It will also be used to refine the design of a larger multi-centre trial to definitively ascertain the impact of using reduced carbohydrate enteral formula on clinical outcomes.
ETHICS AND TRIAL REGISTRATION: Ethical approval was obtained from the local Research Ethics Committee (HREC Approval HREC/2021/QMS/74667). The trial was registered on the Clinical Trials Registry with registration number ACTRN12621000859886.
