The Effect of Intravenous Lipids on Lung Function in Acute Respiratory Distress Syndrome (ARDS)
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: ClinOleic 20%; Intralipid 20%
Intervention description: 96 hour continuous infusion.; 96 hour continuous infusion.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: ARDS; Parenteral; Pharmaconutrition

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.
    

Eligibility criteria:

        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