Parenteral Fish Oil in Sepsis
| ISRCTN | ISRCTN89432944 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89432944 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Intensive Care Unit
Hospital Padre Americo
Guilhufe
Penafiel
4560-007
Portugal
Study information
| Study design | Randomised controlled parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Parenteral fish oil |
| Primary outcome measure | 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 study start date | 01/03/2007 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
4560-007
Portugal
Sponsor information
Hospital Padre Americo (Portugal)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr E Lafuente
Intensive Care Unit
Guilhufe
Penafiel
4560-007
Portugal
"ROR" |
https://ror.org/003zfh275 |
|---|
Funders
Funder type
Other
Investigator initiated and funded (UK) - provided by UK honoraria
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
