Effect of an omega-3 fatty acid enriched lipid emulsion on acute respiratory distress syndrome (ARDS)
| ISRCTN | ISRCTN63673813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63673813 |
| Secondary identifying numbers | BBM-PH-H-0229 |
- Submission date
- 23/06/2008
- Registration date
- 30/06/2008
- Last edited
- 14/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Mercè Planas
Scientific
Scientific
Unitat de Suport Nutricional
Hospital General Universitari Vall dHebron
Passeig Vall dHebron 119-129
Barcelona
08035
Spain
Study information
| Study design | Prospective double blind randomised single-centre phase III study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | The lipid emulsions generally used in the parenteral nutrition of critically ill patients are rich in long-chain triglycerides (LCT), especially linoleic acid. These preparations guarantee an optimal energy supply and prevent deficiency in essential fatty acids. These fatty acids can alter pulmonary gas exchange due to their potentially proinflammatory properties. Several studies suggest that lipid emulsions effects on pulmonary gas exchange could be mediated by arachidonic acid derivates, especially eicosanoids. Linoleic acid is the precursor, through the arachidonic acid pathway, of series 2 and 4 eicosanoids. These molecules are mediators of inflammation with intense biological activity. A variety of studies show that eicosanoids have different effects on the lungs, acting on immune response, vasomotor tone, and/or inflammatory response. Polyunsaturated fatty acids of the n-3 series (omega-3), which are derived from alpha-linolenic acid, as well as their derivatives eicosapentaenoic acid and docosahexaenoic acid are also precursors of biologically active substances, e.g. the series 3 and 5 eicosanoids. These molecules use the same metabolic routes and compete for the same elongases and desaturases as linoleic and arachidonic, but ultimately they are mediators that have a much less active biological profile than linoleic acid derivatives. Due to the different composition in fatty acids of diversal lipid emulsions, its endovenous administration could have different physiologic and pharmacologic effects beside energetic properties in high risk patients. In this study we will try to evaluate the effect and security of a lipid emulsion enriched with omega 3 fatty acids, in patients with acute respiratory distress syndrome (ARDS). Our hypothesis was that the use of an emulsion with less linoleic acid and enriched with omega-3 would reduce the pulmonary impact in patients with ARDS. |
| Ethics approval(s) | Ethics approval received from the Committee of Clinical Trials of the Vall d'Hebron General University Hospital of Barcelona on the 27th January 1999. |
| Condition | Acute respiratory distress syndrome (ARDS) |
| Intervention | In the first 48 hours after the diagnosis of ARDS and before receiving artificial nutrition, patients were randomised into two different groups: Group A received the study emulsion Lipoplus® 20% (B. Braun Medical; 50% MCT, 40% LCT, 10% omega-3) Group B received the control emulsion Intralipid® 20% (Fresenius Kabi; 100% LCT) The lipid emulsions were administered during 12 hours at a rate of 0.12 g/kg/h. Measurements were made at baseline (immediately before the administration of lipid emulsions [t = 0]), at the end of administration (t = 12) and 24 hours after the beginning of lipid emulsion. Basic parameters of pulmonary mechanics, arterial and mixed venous gas analysis, haemodynamic parameters, and oxygen transport were measured at all stages. Measurement of different plasmatic eicosanoids (Thromboxane B2 [TXB2], 6-Keto-prostaglandin-F1 alfa and Leukotriene B4 [LTB4]) in mixed venous and arterial blood samples also took place during all the study periods. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lipoplus®, Intralipid® |
| Primary outcome measure | 1. Initial tolerance and security of an omega-3 fatty acid enriched lipid emulsion in patients with ARDS, evaluated during all the treatment period and up to the end of the ICU period 2. Effects on haemodynamics and respiratory function, measured at baseline, 6 hours, 12 hours (parenteral treatment ending), 24 hours (12 hours after parenteral ending) |
| Secondary outcome measures | Effects on eicosanoid synthesis, measured at baseline, 6 hours, 12 hours and 24 hours. |
| Overall study start date | 10/08/2000 |
| Overall study end date | 13/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 16 |
| Participant inclusion criteria | 1. Patients aged 18 - 85 years, either sex 2. ARDS in the first 48 hours of admission 3. Intolerance of enteral nutrition |
| Participant exclusion criteria | 1. Aged younger than 18 or older than 85 years 2. Pregnancy 3. Liver failure 4. Human immunodeficiency virus (HIV) positivity 5. Leukopenia (less than 3500 mm^3) 6. Thrombocytopenia (less than 100,000 mm^3) 7. Severe renal insufficiency (creatinine greater than 6 mg/dl) or need for renal dialysis 8. Signs of heart failure 9. Transplantation 10. Multiple blood transfusions 11. Participation in other clinical trials simultaneously or in the last 60 days 12. Treatment with nitrous oxide or corticoids (prednisolone 2 mg/kg/d or equivalent) 13. Multiple organ failure 14. Severe dyslipidemia, or propofol treatment |
| Recruitment start date | 10/08/2000 |
| Recruitment end date | 13/03/2003 |
Locations
Countries of recruitment
- Spain
Study participating centre
Unitat de Suport Nutricional
Barcelona
08035
Spain
08035
Spain
Sponsor information
B. Braun Medical S.A. (Spain)
Industry
Industry
Carretera de Terrassa, 121
Rubí (Barcelona)
08191
Spain
| Website | http://www.bbraun.es/ |
|---|---|
"ROR" |
https://ror.org/04sdeyq07 |
Funders
Funder type
Industry
B. Braun Medical S.A. (Spain)
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 | 08/04/2011 | Yes | No |
