Diabetes-Specific Formulae Versus Standard Formulae as Enteral Nutrition to Treat Hyperglycemia in Critically Ill Patients: Protocol for a Randomized Controlled Feasibility Trial - PubMed (original) (raw)

Diabetes-Specific Formulae Versus Standard Formulae as Enteral Nutrition to Treat Hyperglycemia in Critically Ill Patients: Protocol for a Randomized Controlled Feasibility Trial

Ra'eesa Doola et al. JMIR Res Protoc. 2018.

Abstract

Background: During critical illness, hyperglycemia is prevalent and is associated with adverse outcomes. While treating hyperglycemia with insulin reduces morbidity and mortality, it increases glycemic variability and hypoglycemia risk, both of which have been associated with an increase in mortality. Therefore, other interventions which improve glycemic control, without these complications should be explored. Nutrition forms part of standard care, but the carbohydrate load of these formulations has the potential to exacerbate hyperglycemia. Specific diabetic-formulae with a lesser proportion of carbohydrate are available, and these formulae are postulated to limit glycemic excursions and reduce patients' requirements for exogenous insulin.

Objective: The primary outcome of this prospective, blinded, single center, randomized controlled trial is to determine whether a diabetes-specific formula reduces exogenous insulin administration. Key secondary outcomes include the feasibility of study processes as well as glycemic variability.

Methods: Critically ill patients will be eligible if insulin is administered whilst receiving exclusively liquid enteral nutrition. Participants will be randomized to receive a control formula, or a diabetes-specific, low glycemic index, low in carbohydrate study formula. Additionally, a third group of patients will receive a second diabetes-specific, low glycemic index study formula, as part of a sub-study to evaluate its effect on biomarkers. This intervention group (n=12) will form part of recruitment to a nested cohort study with blood and urine samples collected at randomization and 48 hours later for the first 12 participants in each group with a secondary objective of exploring the metabolic implications of a change in nutrition formula. Data on relevant medication and infusions, nutrition provision and glucose control will be collected to a maximum of 48 hours post randomization. Baseline patient characteristics and anthropometric measures will be recorded. A 28-day phone follow-up will explore weight and appetite changes as well as blood glucose control pre and post intensive care unit (ICU) discharge.

Results: Recruitment commenced in February 2015 with an estimated completion date for data collection by May 2018. Results are expected to be available late 2018.

Conclusions: This feasibility study of the effect of diabetes-specific formulae on the administration of insulin in critically ill patients and will inform the design of a larger, multi-center trial.

Trial registration: Australian New Zealand Clinical Trial Registry (ANZCTR):12614000166673; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614000166673 (Archived by WebCite at http://www.webcitation.org/6xs0phrVu).

Keywords: enteral formula; glucose; glycemic control; low carbohydrate; nutrition; tube formula.

©Ra'eesa Doola, Alwyn S Todd, Josephine M Forbes, Adam M Deane, Jeffrey J Presneill, David J Sturgess. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.04.2018.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1

Figure 1

Blinding of formulae.

Figure 2

Figure 2

Study flow diagram of recruitment, randomization and study conduct. Once consented patients will be randomized on a 1:1:1 ratio until there are 12 patients who have complete blood and urine sample sets from each group to form the biomarker sub-study. Thereafter the study will proceed with two arms as indicated. Finalized patient numbers have not been provided as this is a feasibility study.

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