Plain English Summary
Background and study aims
Critically ill patients typically lose a lot of muscle mass despite what we feed them. Minimising muscle loss during critical illness is crucial to improving short and long term physical function after critical illness and to provide an earlier independence for this vulnerable patient group. The aim of this study is to try and determine when is the best time to feed critically ill patients so that we can try and minimise their muscle loss. We will also find out whether an amino acid supplement is useful to minimise muscle loss.
Who can participate?
Trauma patients (head and multiple trauma) over 18 years of age admitted to the Intensive Care Unit (ICU) or High Dependency Unit (HDU) and mechanically ventilated for over 48 hours.
What does the study involve?
Participants are randomly allocated to one of two groups. One group receives usual care - standard enteral feeding (tube feeding) given according to need. The other group receives an essential amino acid supplement given twice daily in addition to standard enteral feeding. Changes in muscle mass are measured with ultrasound so that we can see if muscle is being broken down or built up. Blood samples are collected to check for inflammation and urine samples are collected to check for muscle breakdown. The number of calories that the patients burn is measured by monitoring what the patients breathe in and out. Patients’ mobility and independent function are assessed with two questionnaires.
What are the possible benefits and risks of participating?
The results of this study will benefit critically ill patients in future by finding the best time to feed them. If essential amino acid supplementation minimises muscle mass loss, patients will benefit from earlier rehabilitation and independence. Blood, urine and breath samples are taken with routine samples to reduce patient discomfort. The essential amino acid supplement is a licensed nutritional supplement. The muscle ultrasound is a non-invasive technique.
Where is the study run from?
Charing Cross Hospital (UK)
When is the study starting and how long is it expected to run for?
September 2010 to March 2013
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Miss Liesl Wandrag
An investigation into inflammatory and nutritional markers during critical illness to identify an indicator of anabolism and to explore a method of attenuating muscle mass loss
The purpose of this study is to try and determine when is the best time to feed critically ill patients so that we can try and minimise their muscle loss. We need to identify when patients build muscle rather than break muscle down and when they are best able to utilise nutrition. This will be achieved by examining both inflammatory and nutritional markers in part 1 of this study. In part 2 we will see if an amino acid supplement is useful to minimise muscle loss.
North West London Research Ethics Committee, 26/05/2010, ref: 10/H0722/40
Randomised interventional and observational cohort study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Intervention group: Essential Amino Acid supplementation given twice daily in addition to standard enteral feed.
Control group: Usual care - Standard enteral feed given according to need.
Primary outcome measures
Muscle change with a muscle ultrasound technique measured daily for 1st week, twice weekly after
Secondary outcome measures
1. Katz & Barthel indexes measured at day 1, 7, 14, 20
2. Indirect calorimetry measured at day 1, 5, 7, 14
3. Inflammatory markers: CRP, Albumin, cytokines measured at day 1, 5, 7, 14
4. Plasma amino acids measured at day 1, 10
5. Protein turnover with stable isotopes measured at day 1, 10, 20
6. Urinary amino acids measured at day 1, 5, 7, 14
Overall trial start date
Overall trial end date
Participant inclusion criteria
Intensive Care Unit (ICU):
Patients mechanically ventilated for > 48h
High Dependency Unit (HDU):
1. Trauma patients > 18 years.
2. Patients should be entered into the trial within 72h of ICU admission.
1. Trauma patients (head and multiple trauma) admitted to Intensive Care expected to be ventilated for > 48h
2. Over 18 years of age
3. Patients should be entered into the trial within 72 hours of ICU admission
4. Male and female participants
5. Between 18 - 95 years
Target number of participants
UK Sample Size: 120; Description: Part 1: Observational study: 80 ICU subjects, 15 HDU subjects. Part 2: Interventional pilot study: 40 subjects (20 in each group).
Participant exclusion criteria
Patients expected to be ventilated for < 48h; Non-trauma HDU patients.
1. Medical ICU patients
2. Surgical (non-trauma) ICU patients
3. Patients enrolled in another interventional clinical trial
4. Patients where enteral feeding is contraindicated
5. Cardiac failure
6. End Stage Renal Failure
7. Chronic Obstructive Pulmonary Disease
8. Chronic liver disease (cirrhosis)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Charing Cross Hospital
Imperial College London (UK)
School of Medicine
Du Cane Road
National Institute for Health Research (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting