Inflammatory and nutritional changes during critical illness
| ISRCTN | ISRCTN79066838 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79066838 |
| Secondary identifying numbers | 8846 |
- 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
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
| Study design | Randomised interventional and observational cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 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(s) | North West London Research Ethics Committee, 26/05/2010, ref: 10/H0722/40 |
| 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 | Supplement |
| Primary outcome measure | 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 study start date | 30/09/2010 |
| Overall study end date | 01/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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 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 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
- England
- United Kingdom
Study participating centre
W6 8RF
United Kingdom
Sponsor information
University/education
School of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
England
United Kingdom
| Website | http://www3.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
