Modulation of gut function using Gut Specific Nutrients in the critically ill
| ISRCTN | ISRCTN61157513 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61157513 |
| Secondary identifying numbers | LREC/04/378 |
- Submission date
- 12/04/2009
- Registration date
- 30/04/2009
- Last edited
- 24/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof John Macfie
Scientific
Scientific
Department of General Surgery
Scarborough General Hospital
Woodlands Drive
Scarborough
YO12 6QL
United Kingdom
Study information
| Study design | Double-blind placebo-controlled randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Modulation of gut function using gut specific nutrients in the critically ill: a double blind, placebo controlled, randomised clinical trial |
| Study acronym | GSN study |
| Study objectives | The aim of this study is to determine whether or not the use of a cocktail of gut specific nutrients would enhance recovery of gut function and to assess if this is associated with other clinical benefits. |
| Ethics approval(s) | Scarborough Hospital Local Research Ethics Committee approved on the 1st March 2004 (ref: LREC/04/378) |
| Health condition(s) or problem(s) studied | Gut failure |
| Intervention | Enrolled patients were randomised to either a control group (receiving placebo) or a study group (receiving a gut specific nutrient cocktail of glutamine, multivitamins and antioxidants [Forceval], probiotics [Trevis] and the prebiotic oligofructose). Total duration of treatment/placebo = 1 month (30 days) Follow-up for both treatment and placebo arms = 3 months |
| Intervention type | Supplement |
| Primary outcome measure | Time to the return of normal gut function, measured hourly from recruitment to return of gut function. |
| Secondary outcome measures | 1. Episodes of feed intolerance, measured daily for duration of stay 2. Numerous nutritional parameters 3. Use of opiates, total quantity measured for duration of stay, day 30 and day 90 4. Fluid balance, measured daily for duration of stay 5. The need for surgery, measured daily for duration of stay, on day 30 and day 90 6. Duration of intravenous infusions, measured daily for duration of stay 7. Serial intestinal permeability, measured on recruitment, on day 30 and day 90 8. Serial Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, measured on recruitment, weekly during admission, on day 30 and day 90 9. Other single organ failures, measured daily for duration of stay, on day 30 and day 90 10. Occurrence of septic, non-septic, and feed-related complications, measured daily for duration of stay, as well as mortality (measured throughout the 90 day follow-up period) and length of ICU and hospital stay (measured on discharge from ICU/hospital) 11. Need for patient readmission, measured after discharge to day 90 12. Total number of general practitioner (GP) visits, measured after discharge to day 90 13. Anthropometric measurements, measured on recruitment, weekly during admission, on day 30 and day 90 14. Hospital anxiety and depression (HAD) scores, measured on recruitment and then on day 30 and day 90 15. Pain and fatigue scores, measured on recruitment, weekly during admission, on day 30 and day 90 |
| Overall study start date | 01/03/2004 |
| Completion date | 30/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | Critically ill patients (aged greater than or equal to 18 years, either sex) with inadequate gut function |
| Key exclusion criteria | 1. Failure to obtain consent (or assent by the next-of-kin) 2. Known intolerance to one or more of the study preparations 3. Aged less than 18 years 4. Pregnancy 5. Patients who are strictly 'nil-by-mouth' and therefore unable to receive the study preparations or appropriate placebos |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 30/07/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of General Surgery
Scarborough
YO12 6QL
United Kingdom
YO12 6QL
United Kingdom
Sponsor information
Scarborough and North East Yorkshire Healthcare NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Scarborough General Hospital
Woodlands Drive
Scarborough
YO12 6QL
England
United Kingdom
| Website | http://www.scarborough.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01b11x021 |
Funders
Funder type
Government
Scarborough and North East Yorkshire Healthcare NHS Trust (UK)
No information available
The Combined Gastroenterology Research Fund (UK)
No information available
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 | results | 01/11/2010 | Yes | No |
