Contact information
Type
Scientific
Primary contact
Dr Mike Stroud
ORCID ID
Contact details
Institute of Human Nutrition
West Wing
Level C
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)1703 796317
M.A.Stroud@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0231150767
Study information
Scientific title
Optimal levels of parenteral nutrition (PN) in the catabolic patient
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/02/2004
Overall trial end date
01/06/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/2004
Recruitment end date
01/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Southampton University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary