Acute respiratory distress syndrome (ARDS) Respiratory Respiratory failure, not elsewhere classified
Conditions
Interventions
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.
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 th
Sponsors
B. Braun Medical S.A. (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 - 85 years, either sex 2. ARDS in the first 48 hours of admission 3. Intolerance of enteral nutrition
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Effects on eicosanoid synthesis, measured at baseline, 6 hours, 12 hours and 24 hours. | — |
Countries
Spain
Outcome results
None listed