The Effect of Intravenous Lipids on Lung Function in Acute Respiratory Distress Syndrome (ARDS)
Status:
Terminated
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the effects of nutritional supplementation with
omega-9 "olive-oil" and omega-6 "soybean oil" based lipid emulsions in the Acute Respiratory
Distress Syndrome (ARDS). The investigators hypothesize that these specific lipids in
combination will immunomodulate the inflammatory reaction that occurs in the lungs of ARDS
subjects. This concept is known as "Pharmaconutrition." These lipids will be given
intravenously so as to assure administration and only as a supplement to enteral nutrition
which all subjects will also receive. The omega-9 will be compared to the omega-6 formulation
which is the only FDA approved formulation of use in the United States since its development
in 1961 by Fresenius-Kabi, Bad Homburg, Germany. The investigators plan to perform a
bronchoscopy with lavage within 24 hours of enrollment, begin the lipid administration and
continue it for 96 hours after which time the investigators will repeat bronchoscopy with
lavage to assess changes. The lipid administration will cease following the second
bronchoscopy. The fluid obtained from lavage combined with serum samples obtained at the time
of bronchoscopy will be analyzed for inflammatory mediators and cell counts. Clinical data
tracing will include but not be limited to: ventilator days, nutritional status, ICU time,
oxygenation and lung compliance, and 30-day mortality.