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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ClinOleic 20%
Intralipid 20%
Sponsored by
Methodist Research Institute, Indianapolis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring ARDS, Parenteral, Pharmaconutrition

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ClinOleic 20%

Intralipid 20%

Arm Description

96 hour continuous infusion.

96 hour continuous infusion.

Outcomes

Primary Outcome Measures

Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations

Secondary Outcome Measures

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

Full Information

First Posted
March 24, 2010
Last Updated
April 25, 2014
Sponsor
Methodist Research Institute, Indianapolis
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1. Study Identification

Unique Protocol Identification Number
NCT01096771
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Unable to secure product from international source, low recruitment rate.
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Methodist Research Institute, Indianapolis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
ARDS, Parenteral, Pharmaconutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ClinOleic 20%
Arm Type
Experimental
Arm Description
96 hour continuous infusion.
Arm Title
Intralipid 20%
Arm Type
Active Comparator
Arm Description
96 hour continuous infusion.
Intervention Type
Drug
Intervention Name(s)
ClinOleic 20%
Intervention Description
96 hour continuous infusion.
Intervention Type
Drug
Intervention Name(s)
Intralipid 20%
Intervention Description
96 hour continuous infusion.
Primary Outcome Measure Information:
Title
Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations
Time Frame
96 hours
Secondary Outcome Measure Information:
Title
Ventilator Days
Time Frame
30 days
Title
PaO2:FiO2 Ratio
Description
PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.
Time Frame
4 days
Title
30 Day Mortality
Time Frame
30 days
Title
New Infection
Description
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.
Time Frame
30 days
Title
Organ Failures
Time Frame
30 days
Title
Biomarkers (C-reactive Protein)
Time Frame
96 hours
Title
Hospital Length of Stay
Time Frame
30 days
Title
Allergic Reactions
Time Frame
96 hours
Title
Hypertriglyceridemia
Description
Defined as triglyceride level >400
Time Frame
96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Naum, MD
Organizational Affiliation
Indiana Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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

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