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.)
Sponsor:
Information provided by (Responsible Party):
W. Graham Carlos, Methodist Research Institute, Indianapolis
ClinicalTrials.gov Identifier:
NCT01096771
First received: March 24, 2010
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Methodist Research Institute, Indianapolis:

Primary Outcome Measures:
  • Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations [ Time Frame: 96 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ventilator Days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • PaO2:FiO2 Ratio [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.

  • 30 Day Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • New Infection [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Biomarkers (C-reactive Protein) [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
  • Hospital Length of Stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Allergic Reactions [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
  • Hypertriglyceridemia [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096771

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

Additional Information:
No publications provided

Responsible Party: W. Graham Carlos, MD, Methodist Research Institute, Indianapolis
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Methodist Research Institute, Indianapolis:
ARDS
Parenteral
Pharmaconutrition

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014