COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01096771
Recruitment Status : Terminated (Unable to secure product from international source, low recruitment rate.)
First Posted : March 31, 2010
Results First Posted : May 26, 2014
Last Update Posted : May 26, 2014
Information provided by (Responsible Party):
W. Graham Carlos, 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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Drug: ClinOleic 20% Drug: Intralipid 20% Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Intravenous Lipid Emulsions on Lung Function in ARDS: A Pilot Study
Study Start Date : June 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
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.

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

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

  3. 30 Day Mortality [ Time Frame: 30 days ]
  4. 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.

  5. Organ Failures [ Time Frame: 30 days ]
  6. Biomarkers (C-reactive Protein) [ Time Frame: 96 hours ]
  7. Hospital Length of Stay [ Time Frame: 30 days ]
  8. Allergic Reactions [ Time Frame: 96 hours ]
  9. Hypertriglyceridemia [ Time Frame: 96 hours ]
    Defined as triglyceride level >400

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01096771

Layout table for location information
United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Methodist Research Institute, Indianapolis
Layout table for investigator information
Principal Investigator: Chris Naum, MD Indiana Clinic
Additional Information:
Layout table for additonal information
Responsible Party: W. Graham Carlos, MD, Methodist Research Institute, Indianapolis Identifier: NCT01096771    
Other Study ID Numbers: Lipids for ARDS
First Posted: March 31, 2010    Key Record Dates
Results First Posted: May 26, 2014
Last Update Posted: May 26, 2014
Last Verified: April 2014
Keywords provided by W. Graham Carlos, Methodist Research Institute, Indianapolis:
Additional relevant MeSH terms:
Layout table for 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