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Parenteral Fish Oil in Sepsis
ISRCTN ISRCTN89432944
DOI 10.1186/ISRCTN89432944
ClinicalTrials.gov identifier
EudraCT number
Public title Parenteral Fish Oil in Sepsis
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
Serial number at source N/A
Study hypothesis Parenteral fish oil will reduce inflammation and improve clinical outcomes in septic patients in the intensive care unit (ICU).
Lay summary
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
Countries of recruitment Portugal
Disease/condition/study domain Systemic inflammatory response syndrome/sepsis
Participants - 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
Participants - exclusion criteria 1. Able to be enterally fed
2. Under 18 years of age
Anticipated start date 01/03/2007
Anticipated end date 31/12/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 25
Interventions 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.
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
Secondary outcome measure(s) 1. Respiratory function at days 0, 1, 2 and 6
2. Mortality up to day 28
Sources of funding Investigator initiated and funded (UK) - provided by UK honoraria
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20085628
Contact name Prof  Estevao  Lafuente
  Address Intensive Care Unit
Hospital Padre Americo
Guilhufe
  City/town Penafiel
  Zip/Postcode 4560-007
  Country Portugal
Sponsor Hospital Padre Americo (Portugal)
  Address c/o Dr E Lafuente
Intensive Care Unit
Guilhufe
  City/town Penafiel
  Zip/Postcode 4560-007
  Country Portugal
Date applied 09/11/2009
Last edited 27/01/2010
Date ISRCTN assigned 17/11/2009
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