Condition category
Infections and Infestations
Date applied
09/11/2009
Date assigned
17/11/2009
Last edited
27/01/2010
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

Prof Estevao Lafuente

ORCID ID

Contact details

Intensive Care Unit
Hospital Padre Americo
Guilhufe
Penafiel
4560-007
Portugal

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of fish oil containing lipid emulsion on plasma phospholipid fatty acids, inflammatory markers, and clinical outcomes in septic patients: a randomised, controlled clinical trial

Acronym

FOS

Study hypothesis

Parenteral fish oil will reduce inflammation and improve clinical outcomes in septic patients in the intensive care unit (ICU).

Ethics approval

Comissão de Ética para a Saúde, Hospital Padre Américo, Penafiel, Portugal, approved on the 7th February 2007 (reg. no.: 1142; chair: Dr Braga da Cunha)

Study design

Randomised controlled parallel 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 the contact details below to request a patient information sheet

Condition

Systemic inflammatory response syndrome/sepsis

Intervention

Total parenteral nutrition including a lipid mixture providing a 50:50 mixture of coconut oil and soybean oil (Nutriflex Lipid Special) versus total parenteral nutrition (Nutriflex Special) including a lipid mixture providing a 50:40:10 mixture of coconut oil, soybean oil and fish oil (Lipoplus). Parenteral nutrition was administered continuously over 24 hours from soon after admission to the ICU until enteral feeding could be initiated, which was beyond day 6. Study samples were collected until day 6 and patient follow-up continued until they left hospital.

Intervention type

Drug

Phase

Not Applicable

Drug names

Parenteral fish oil

Primary outcome measures

1. Plasma phospholipid fatty acid status at days 0, 1, 2 and 6
2. Plasma inflammatory cytokines at days 0, 1, 2 and 6
3. Inflammatory cytokine production by endotoxin stimulated whole blood at days 0, 1, 2 and 6
4. Length of ICU and hospital stay

Secondary outcome measures

1. Respiratory function at days 0, 1, 2 and 6
2. Mortality up to day 28

Overall trial start date

01/03/2007

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Systemic inflammatory response syndrome or sepsis
2. Predicted to need parenteral nutrition
3. Assigned to ICU
4. Over 18 years of age, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

Participant exclusion criteria

1. Able to be enterally fed
2. Under 18 years of age

Recruitment start date

01/03/2007

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Portugal

Trial participating centre

Intensive Care Unit
Penafiel
4560-007
Portugal

Sponsor information

Organisation

Hospital Padre Americo (Portugal)

Sponsor details

c/o Dr E Lafuente
Intensive Care Unit
Guilhufe
Penafiel
4560-007
Portugal

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded (UK) - provided by UK honoraria

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20085628

Publication citations

  1. Results

    Barbosa VM, Miles EA, Calhau C, Lafuente E, Calder PC, Effects of a fish oil containing lipid emulsion on plasma phospholipid fatty acids, inflammatory markers, and clinical outcomes in septic patients: a randomized, controlled clinical trial., Crit Care, 2010, 14, 1, R5, doi: 10.1186/cc8844.

Additional files

Editorial Notes