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The Effect of Intravenous Lipids on Lung Function in Acute Respiratory Distress Syndrome (ARDS)

This study has been terminated.
(Unable to secure product from international source, low recruitment rate.)
Information provided by (Responsible Party):
W. Graham Carlos, Methodist Research Institute, Indianapolis Identifier:
First received: March 24, 2010
Last updated: April 25, 2014
Last verified: April 2014
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.

Condition Intervention Phase
Acute Respiratory Distress Syndrome Drug: ClinOleic 20% Drug: Intralipid 20% Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Intravenous Lipid Emulsions on Lung Function in ARDS: A Pilot Study

Resource links provided by NLM:

Further study details as provided by W. Graham Carlos, Methodist Research Institute, Indianapolis:

Primary Outcome Measures:
  • Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations [ Time Frame: 96 hours ]

Secondary Outcome Measures:
  • Ventilator Days [ Time Frame: 30 days ]
  • PaO2:FiO2 Ratio [ Time Frame: 4 days ]
    PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.

  • 30 Day Mortality [ Time Frame: 30 days ]
  • New Infection [ Time Frame: 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 [ Time Frame: 30 days ]
  • Biomarkers (C-reactive Protein) [ Time Frame: 96 hours ]
  • Hospital Length of Stay [ Time Frame: 30 days ]
  • Allergic Reactions [ Time Frame: 96 hours ]
  • Hypertriglyceridemia [ Time Frame: 96 hours ]
    Defined as triglyceride level >400

Enrollment: 14
Study Start Date: June 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ClinOleic 20%
96 hour continuous infusion.
Drug: ClinOleic 20%
96 hour continuous infusion.
Active Comparator: Intralipid 20%
96 hour continuous infusion.
Drug: Intralipid 20%
96 hour continuous infusion.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01096771

United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Methodist Research Institute, Indianapolis
Principal Investigator: Chris Naum, MD Indiana Clinic
  More Information

Additional Information:
Responsible Party: W. Graham Carlos, MD, Methodist Research Institute, Indianapolis Identifier: NCT01096771     History of Changes
Other Study ID Numbers: Lipids for ARDS
Study First Received: March 24, 2010
Results First Received: March 26, 2014
Last Updated: April 25, 2014

Keywords provided by W. Graham Carlos, Methodist Research Institute, Indianapolis:

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions processed this record on June 21, 2017