Optimal levels of parenteral nutrition (PN) in the catabolic patient
| ISRCTN | ISRCTN44082375 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44082375 |
| Protocol serial number | N0231150767 |
| Sponsor | Department of Health |
| Funders | Southampton University Hospitals NHS Trust (UK), NHS R&D Support Funding (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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(s) |
1. Anthropometric changes |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
SO16 6YD
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/07/2016: No publications found, verifying study status with principal investigator.
