Parenteral Fish Oil in Sepsis

ISRCTN	ISRCTN89432944
DOI	https://doi.org/10.1186/ISRCTN89432944
Protocol serial number	N/A
Sponsor	Hospital Padre Americo (Portugal)
Funder	Investigator initiated and funded (UK) - provided by UK honoraria

Submission date: 09/11/2009
Registration date: 17/11/2009
Last edited: 27/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Estevao Lafuente
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled parallel trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	FOS
Study objectives	Parenteral fish oil will reduce inflammation and improve clinical outcomes in septic patients in the intensive care unit (ICU).
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Parenteral fish oil
Primary outcome measure(s)	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
Key secondary outcome measure(s)	1. Respiratory function at days 0, 1, 2 and 6 2. Mortality up to day 28
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	25
Key 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
Key exclusion criteria	1. Able to be enterally fed 2. Under 18 years of age
Date of first enrolment	01/03/2007
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Portugal

Study participating centre

Intensive Care Unit

Penafiel
4560-007
Portugal

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes