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

NCT01096771 | Terminated Phase 2 Results DMC

• 1 other identifier: Lipids for ARDS
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS; Parenteral; Pharmaconutrition

Outcome Measures

Primary Outcomes (1)

• Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations

  96 hours

Secondary Outcomes (9)

• Ventilator Days

  30 days

• PaO2:FiO2 Ratio

  4 days

• 30 Day Mortality

  30 days

• New Infection

  30 days

• Organ Failures

  30 days

Study Arms (2)

ClinOleic 20%

EXPERIMENTAL

96 hour continuous infusion.

Drug: ClinOleic 20%

Intralipid 20%

ACTIVE COMPARATOR

96 hour continuous infusion.

Drug: Intralipid 20%

Interventions

ClinOleic 20% DRUG

96 hour continuous infusion.

ClinOleic 20%

Intralipid 20% DRUG

96 hour continuous infusion.

Intralipid 20%

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Methodist Research Institute, Indianapolis: lead

Study Sites (1)

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Results Point of Contact

• Title: Dr. William Carlos
• Organization: Indiana University School of Medicine

wcarlos@iu.edu

3178807819

Study Officials

• Chris Naum, MD

  Indiana Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 31, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 26, 2014
• Results First Posted: May 26, 2014

Record last verified: 2014-04

Locations

US (1)