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Targeted Full Energy and Protein Delivery in Critically Ill Patients: A Pilot Randomised Control Trial

Targeted Full Energy and Protein Delivery in Critically Ill Patients: A Pilot Randomised Control Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000876594
Acronym
FEED Trial
Enrollment
60
Registered
2015-08-21
Start date
2015-08-17
Completion date
2017-07-20
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Intensive care admissions, particularly for prolonged periods are often associated with muscle weakness, deconditioning, malnutrition and impaired long-term functional status. Nutrition is a potential modifiable factor to attenuate this deterioration. However defining what optimal nutrition is for critically ill patients in order to improve their outcomes remains controversial and needs further investigation. Despite feeding protocols, internationally and at the Royal Melbourne Hospital (RMH), patients continue to receive inadequate energy and protein compared to recommended targets. Results from our recently completed observational study in Intensive Care at RMH showed that accumulating an energy debt over an Intensive Care Unit (ICU) admission is associated with decreased muscle strength, physical function and the diagnosis of ICU Acquired Weakness (ICUAW). Patients with poorer strength and suboptimal physical function had a longer ICU length of stay and a higher requirement for inpatient rehabilitation, which is associated with increased health costs. This pilot randomised controlled trial aims to determine if a feeding protocol based on energy and protein targets, using a volume approach decreases muscle wastage and improves muscle strength and functional outcomes at discharge from the ICU compared to standard care. Patients will be randomised to standard care or the targeted feeding protocol which aims to provide 25kcal per kilogram and 1.5g protein per kilogram, which is in line with international best practice guidelines. The study period is from day of enrolment until ICU day 15 or discharge from ICU. Data collection will be the same for both groups and will include demographic data, the amount of energy and protein delivered, nutritional markers; such as weight and nutritional status and outcome such as length of stay and length of mechanical ventilation. Muscle strength and physical function will be assessed by the physiotherapist using standardised methods, which have been validated in the ICU. Muscle mass will be measured using ultrasound, which is a non-invasive technique, which has been safely used in the ICU. Data from this study will assist in informing future research studies to answer important clinical questions, including; should higher protein recommendations be targeted and what are the effects of improved calorie and protein delivery on functional outcomes for patients. This study will provide feasibility data to inform large multicentre randomised control trials.

Interventions

The intervention group will receive their nutrition care based on the FEED protocol. This protocol has been devised in order to optimise both energy and protein delivery, in line with best practise guidelines. A high protein feed (Nutrison Protein plus 1.25kcal/ml) will be used in order to meet higher protein targets of 1.5g/kg/day IBW. A volume based approach will be used to deliver 25kcal/kg IBW. If the feeds are interrupted the feeding rate will be adjusted to ensure the target volume is del

The intervention group will receive their nutrition care based on the FEED protocol. This protocol has been devised in order to optimise both energy and protein delivery, in line with best practise guidelines. A high protein feed (Nutrison Protein plus 1.25kcal/ml) will be used in order to meet higher protein targets of 1.5g/kg/day IBW. A volume based approach will be used to deliver 25kcal/kg IBW. If the feeds are interrupted the feeding rate will be adjusted to ensure the target volume is delivered over a 24 hour period. Supplementary protein will be provided using Beneprotein, in 7g boluses, to ensure the patient meets a protein target of 1.5g/kg/day IBW. The intervention will be provided continuously over a 24 hour period, while the participant is receiving enteral feeds or up until day 15 of the ICU admission.

Sponsors

Royal Melbourne Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adutls who are 18 years of Age and Mechanically ventilated for 48hrs, with no plans to extubate

Exclusion criteria

Patients who have a contraindication to enteral feeding; A limit of medical treatment order in place; Pre-morbid disability causing inability to ambulate > 10m independently (+/- gait aid) Pregnancy; The attending physician does not support inclusion

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026