Optimal levels of parenteral nutrition (PN) in the catabolic patient
| ISRCTN | ISRCTN44082375 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44082375 |
| Secondary identifying numbers | N0231150767 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 18/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mike Stroud
Scientific
Scientific
Institute of Human Nutrition
West Wing, Level C
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)1703 796317 |
|---|---|
| M.A.Stroud@soton.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| 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 contact details to request a participant information sheet |
| Scientific title | Optimal levels of parenteral nutrition (PN) in the catabolic patient |
| Study objectives | To determine whether intravenous provision of nutrition at levels lower than those currently recommended in guidelines from the British Association of Parenteral and Enteral Nutrition (BAPEN) decrease PN related complications and are beneficial to clinical outcome. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Parenteral nutrition |
| Intervention | A double blind, randomised trial of parenteral nutrition (PN) support during the first five days of feeding at around the mid-range of current BAPEN recommendations (30 Kcal/kg non-protein energy + 0.25 gN/kg) VS. levels equating the minimum 'maintenance' feeding for a healthy resting individual (15 Kcal/kg non-protein energy + 0.125 gN/kg) |
| Intervention type | Other |
| Primary outcome measure | 1. Anthropometric changes 2. Haematological and biochemical disturbances 3. Clinical outcomes - infections, fluid balance and oedema, duration of PN, length of hospital stay, and mortality |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2004 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | All consenting adults requiring PN, who do not require specialised regimes to meet their clinical needs. Preliminary analysis of the data will be undertaken once 50 subjects are recruited to each arm. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/02/2004 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Southampton University Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding (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 |
Editorial Notes
18/07/2016: No publications found, verifying study status with principal investigator.
