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
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
-
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.