Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
18/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

18/07/2016: No publications found, verifying study status with principal investigator.