Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
11/07/2016
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 Mark Palazzo

ORCID ID

Contact details

Intensive Care Unit
Charing Cross Hospital
Fulham Palace Road
Hammersmith
London
W6 8RF
United Kingdom
+44 (0)20 8846 7018
m.palazzo@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0016141094

Study information

Scientific title

The incidence of ventilator associated pneumonia (VAP) in critically ill patients: comparison of enteral (EN) versus parenteral (PN) nutrition support

Acronym

Study hypothesis

Can the incidence of ventilator associated pneumonia be reduced by parenteral nutrition during the acute phase of critical illness?

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

Nutrition support

Intervention

Prospective randomised open clinical study taking place at a single centre (ICU_CXH). Patients will be randomised to enteral (EN) versus parenteral (PN) nutrition support.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Incidence of ventilator associated pneumonia
2. The number of ventilator free days
3. ICU length of stay
4. ICU mortality

Secondary outcome measures

Not provided at time of registration

Overall trial start date

29/03/2004

Overall trial end date

29/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients expected to require ventilation for 5 or more days

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

29/03/2004

Recruitment end date

29/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Charing Cross Hospital
London
W6 8RF
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

Hammersmith Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support (UK) - Funding 2004/05

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

11/07/2016: No publications found, verifying study status with principal investigator.