Effect of an omega-3 fatty acid enriched lipid emulsion on acute respiratory distress syndrome (ARDS)

Completed

• Conditions: Acute respiratory distress syndrome (ARDS); Respiratory; Respiratory failure, not elsewhere classified

• Registration Number: ISRCTN63673813
• Lead Sponsor: B. Braun Medical S.A. (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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

Name	Time	Method
Effects on eicosanoid synthesis, measured at baseline, 6 hours, 12 hours and 24 hours.