The Effect of Intravenous Lipids on Lung Function in Acute Respiratory Distress Syndrome (ARDS)
Status: | Completed |
---|---|
Conditions: | Hospital, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | June 2010 |
End Date: | June 2014 |
The Effect of Intravenous Lipid Emulsions on Lung Function in ARDS: A Pilot Study
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.
Inclusion Criteria:
- diagnosed with predisposing condition causing ARDS
- are mechanically ventilated through an endotracheal tube
- have enteral feeding access
- have central venous access
- have a PaO2:FiO2 ratio of less than 200
- have bilateral pulmonary infiltrates on chest x-ray
Exclusion Criteria:
- sedation requiring the use of diprivan (after enrollment)
- a clinical diagnosis of left ventricular failure
- lung cancer
- hematologic malignancy
- severe dyslipidemia
- condition precluding bronchoscopy including inability to maintain oxygen saturations
greater than 90% per pulse oximetry despite conventional mechanical ventilation
- severe immunosuppression
- use of NSAIDS within previous 24 hours
- HIV positive
- pregnancy
- hypersensitivity to egg or soybean oil
- active myocardial infarction
- acute pancreatitis if complicated by hypertriglyceridemia
- severe sepsis with 2 or more organ failures
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