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

NCT ID: NCT01096771

Last Updated: 2014-05-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ClinOleic 20%

96 hour continuous infusion.

Group Type: EXPERIMENTAL

ClinOleic 20%

Intervention Type: DRUG

96 hour continuous infusion.

Intralipid 20%

96 hour continuous infusion.

Group Type: ACTIVE_COMPARATOR

Intralipid 20%

Intervention Type: DRUG

96 hour continuous infusion.

Interventions

ClinOleic 20%

96 hour continuous infusion.

Intervention Type: DRUG

Intralipid 20%

96 hour continuous infusion.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Methodist Research Institute, Indianapolis

OTHER

Sponsor Role: lead

Responsible Party

W. Graham Carlos

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris Naum, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana Clinic

Locations

Methodist Hospital

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

Lipids for ARDS

Identifier Type: -

Identifier Source: org_study_id