Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial)

Kate Fetterplace, Adam M Deane, Audrey Tierney, Lisa Beach, Laura D Knight, Thomas Rechnitzer, Adrienne Forsyth, Marina Mourtzakis, Jeffrey Presneill, Christopher MacIsaac, Kate Fetterplace, Adam M Deane, Audrey Tierney, Lisa Beach, Laura D Knight, Thomas Rechnitzer, Adrienne Forsyth, Marina Mourtzakis, Jeffrey Presneill, Christopher MacIsaac

Abstract

Background: Current guidelines for the provision of protein for critically ill patients are based on incomplete evidence, due to limited data from randomised controlled trials. The present pilot randomised controlled trial is part of a program of work to expand knowledge about the clinical effects of protein delivery to critically ill patients. The primary aim of this pilot study is to determine whether an enteral feeding protocol using a volume target, with additional protein supplementation, delivers a greater amount of protein and energy to mechanically ventilated critically ill patients than a standard nutrition protocol. The secondary aims are to evaluate the potential effects of this feeding strategy on muscle mass and other patient-centred outcomes.

Methods: This prospective, single-centred, pilot, randomised control trial will include 60 participants who are mechanically ventilated and can be enterally fed. Following informed consent, the participants receiving enteral nutrition in the intensive care unit (ICU) will be allocated using a randomisation algorithm in a 1:1 ratio to the intervention (high-protein daily volume-based feeding protocol, providing 25 kcal/kg and 1.5 g/kg protein) or standard care (hourly rate-based feeding protocol providing 25 kcal/kg and 1 g/kg protein). The co-primary outcomes are the average daily protein and energy delivered to the end of day 15 following randomisation. The secondary outcomes include change in quadriceps muscle layer thickness (QMLT) from baseline (prior to randomisation) to ICU discharge and other nutritional and patient-centred outcomes.

Discussion: This trial aims to examine whether a volume-based feeding protocol with supplemental protein increases protein and energy delivery. The potential effect of such increases on muscle mass loss will be explored. These outcomes will assist in formulating larger randomised control trials to assess mortality and morbidity.

Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12615000876594 UTN: U1111-1172-8563.

Keywords: Critical care; Critical illness; Dietary protein; Enteral nutrition; Intensive care; Nutritional requirements; Nutritional support.

Conflict of interest statement

This study is being conducted in full accordance with the National Statement on Ethical Conduct in Human Research (2007), the Guidelines for Good Clinical Research Practice and Melbourne Health Research Policies and Guidelines. This study was approved by the Melbourne Health human research ethics committee (project number 2015.048), on the 11th of May 2015 and was also approved by the La Trobe University Human Ethics Committee on the 3rd of June 2015 under the same project number. As outlined above, all eligible patients will be mechanically ventilated and unable to consent to participation, informed consent will be obtained from the person responsible as per local laws.Not applicable.KF has received conference/travel grants from Baxter, Fresenius Kabi, and Nestle Health Science (not related to this study). AMD or his institution have received honoraria or project grant funding from Baxter, Fresenius Kabi, GSK, Medtronic, and Takeda.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow diagram: flow diagram of patients recruited and study conduct. Abbreviations: MV mechanically ventilated, LOMT limit of medical treatment, yo years old, FEED Protocol intervention
Fig. 2
Fig. 2
FEED protocol: how nutrition will be delivered in the intervention group. Abbreviations: kg kilogramme, IBW ideal body weight, g gram, ml millilitre, H20 water
Fig. 3
Fig. 3
Study events, data collection, and outcome measures. *Baseline data includes age, gender, body mass index, admission diagnosis, Charlson Comorbidity Index, APACHE II score, SOFA Score, Katz Activities of Daily living (ADL) index, dietitian estimation of energy, and protein requirements. **Daily ICU data includes interruptions to feeding, fluid balance, feeding intolerance (gastric residual volumes), diarrhoea (> 300 ml per day), the presence of sepsis, renal failure, urea and creatinine levels, blood sugar levels and insulin dose (unit/day). Abbreviations: FEED protocol intervention, ICU intensive care unit, QMLT quadriceps muscle layer thickness, SGA subjective globe assessment, MUAC mid upper arm circumference, LOS length of stay, MV mechanical ventilation, D/C discharge
Fig. 4
Fig. 4
RMH ICU enteral feeding procedure

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