The Effect of Intravenous Lipids on Lung Function in Acute Respiratory Distress Syndrome (ARDS)
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Registration Number
- NCT01096771
- Lead Sponsor
- Methodist Research Institute, Indianapolis
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ClinOleic 20% ClinOleic 20% 96 hour continuous infusion. Intralipid 20% Intralipid 20% 96 hour continuous infusion.
- Primary Outcome Measures
Name Time Method Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations 96 hours
- Secondary Outcome Measures
Name Time Method Ventilator Days 30 days PaO2:FiO2 Ratio 4 days PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.
30 Day Mortality 30 days New Infection 30 days We will use standard clinical criteria including but not limited to: fever, pyuria, new inflitrate on chest x-ray, positive blood cultures, abscess detected on imaging, leukocytosis, and positive skin or soft-tissue cultures to identify presence of new bacterial infections occurring after enrollment.
Organ Failures 30 days Biomarkers (C-reactive Protein) 96 hours Hospital Length of Stay 30 days Allergic Reactions 96 hours Hypertriglyceridemia 96 hours Defined as triglyceride level \>400
Trial Locations
- Locations (1)
Methodist Hospital
🇺🇸Indianapolis, Indiana, United States