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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01096771
• Other study ID #: Lipids for ARDS
• Status: Terminated
• Phase: Phase 2
• First received: March 24, 2010
• Last updated: April 25, 2014
• Start date: June 2010
• Est. completion date: November 2012

Study information

• Verified date: April 2014
• Source: Methodist Research Institute, Indianapolis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• ClinOleic 20%
96 hour continuous infusion.
• Intralipid 20%
96 hour continuous infusion.

Locations

Country	Name	City	State
United States	Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Research Institute, Indianapolis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations		96 hours	No
Secondary	Ventilator Days		30 days	No
Secondary	PaO2:FiO2 Ratio	PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.	4 days	No
Secondary	30 Day Mortality		30 days	Yes
Secondary	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	Yes
Secondary	Organ Failures		30 days	Yes
Secondary	Biomarkers (C-reactive Protein)		96 hours	No
Secondary	Hospital Length of Stay		30 days	No
Secondary	Allergic Reactions		96 hours	Yes
Secondary	Hypertriglyceridemia	Defined as triglyceride level >400	96 hours	Yes

External Links

•   Methodist Research Institute