Clinical trial NCT01096771: The Effect of Intravenous Lipids on Lung Function in Acute Respiratory Distress Syndrome (ARDS)
Official title: The Effect of Intravenous Lipid Emulsions on Lung Function in ARDS: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
Parenteral
Pharmaconutrition
Lead sponsor: Methodist Research Institute, Indianapolis
Sponsor class: OTHER
First posted: 2010-03-31
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations
timeFrame: 96 hours
Secondary outcomes:
measure: Ventilator Days
timeFrame: 30 days
measure: PaO2:FiO2 Ratio
timeFrame: 4 days
measure: 30 Day Mortality
timeFrame: 30 days
measure: New Infection
timeFrame: 30 days
measure: Organ Failures
timeFrame: 30 days
measure: Biomarkers (C-reactive Protein)
timeFrame: 96 hours
measure: Hospital Length of Stay
timeFrame: 30 days
measure: Allergic Reactions
timeFrame: 96 hours
measure: Hypertriglyceridemia
timeFrame: 96 hours
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana Clinic
name: Chris Naum, MD
role: PRINCIPAL_INVESTIGATOR
References: