Condition category
Not Applicable
Date applied
25/07/2012
Date assigned
30/07/2012
Last edited
15/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Miss Liesl Wandrag

ORCID ID

Contact details

Imperial College Healthcare NHS Trust
Charing Cross Hospital
Nutrition and Dietetic Department
Lab block 13th floor
Fulham Palace Road
London
W6 8RF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8846

Study information

Scientific title

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

Acronym

Study hypothesis

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.

Ethics approval

North West London Research Ethics Committee, 26/05/2010, ref: 10/H0722/40

Study design

Randomised interventional and observational cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Critical care

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Muscle change with a muscle ultrasound technique measured daily for 1st week, twice weekly after

Secondary outcome measures

Functional outcomes:
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

30/09/2010

Overall trial end date

01/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Part 1:
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.

Part 2:
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

Participant type

Patient

Age group

Adult

Gender

Both

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

Part 1:
Patients expected to be ventilated for < 48h; Non-trauma HDU patients.

Part 2:
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

30/09/2010

Recruitment end date

01/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Charing Cross Hospital
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

School of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

Publication summary

Publication citations

Additional files

Editorial Notes

15/01/2016: Plain English summary added.