Inflammatory and nutritional changes during critical illness
| ISRCTN | ISRCTN79066838 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79066838 |
| Protocol serial number | 8846 |
| Sponsor | Imperial College London (UK) |
| Funder | National Institute for Health Research (UK) |
- Submission date
- 25/07/2012
- Registration date
- 30/07/2012
- Last edited
- 15/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
Imperial College Healthcare NHS Trust
Charing Cross Hospital
Nutrition and Dietetic Department
Lab block 13th floor
Fulham Palace Road
London
W6 8RF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional and observational cohort study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | North West London Research Ethics Committee, 26/05/2010, ref: 10/H0722/40 |
| Health condition(s) or problem(s) studied | 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 | Supplement |
| Primary outcome measure(s) |
Muscle change with a muscle ultrasound technique measured daily for 1st week, twice weekly after |
| Key secondary outcome measure(s) |
Functional outcomes: |
| Completion date | 01/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 30/09/2010 |
| Date of final enrolment | 01/03/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
W6 8RF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | feasibility study results in ICU patients | 11/09/2019 | 13/09/2019 | Yes | No |
| Results article | results in ICU patients | 14/11/2019 | 15/11/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/11/2019: Publication reference added.
13/09/2019: Publication reference added.
29/03/2018: No publications found, verifying study status with principal investigator.
15/01/2016: Plain English summary added.
