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

The Effect of Intravenous Lipid Emulsions on Lung Function in ARDS: A Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Drug: ClinOleic 20%; Drug: Intralipid 20%

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations	96 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator Days		30 days
PaO2:FiO2 Ratio	PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.	4 days
30 Day Mortality		30 days
New Infection	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.	30 days
Organ Failures		30 days
Biomarkers (C-reactive Protein)		96 hours
Hospital Length of Stay		30 days
Allergic Reactions		96 hours
Hypertriglyceridemia	Defined as triglyceride level >400	96 hours

Collaborators and Investigators

• Sponsor: Methodist Research Institute, Indianapolis
• Investigators: Principal Investigator: Chris Naum, MD, Indiana Clinic

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: March 30, 2010
• First Posted (Estimate): March 31, 2010

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: April 25, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: ARDS; Parenteral; Pharmaconutrition
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: Lipids for ARDS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No