Condition category
Infections and Infestations
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/12/2014
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 Gerard Dempsey

ORCID ID

Contact details

Critical Care Unit
Anaesthesia Department
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom
+44 (0)151 529 5152
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0025128397

Study information

Scientific title

Randomised controlled trial of immune nutrition in severe sepsis

Acronym

Study hypothesis

Does use of immune-enhancing enteral feed, when compared to standard feed, decrease infective complications, number of organ dysfunctions, length of ventilator dependent days and length of critical care and hospital stay?

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

Condition

Injury, Occupational Diseases, Poisoning: Sepsis

Intervention

Enteral feed vs standard feed

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2003

Overall trial end date

01/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

400 subjects aged 16+

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

400

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2003

Recruitment end date

01/11/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Aintree
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Aintree Hospitals NHS Trust (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