A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)

NCT ID: NCT00351533

Last Updated: 2011-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-08-31

Brief Summary

The purpose of this study is to determine whether fish oil (containing omega-3 fatty acids) given enterally is safe and effective in reducing lung and systemic inflammation seen in acute lung injury.

Detailed Description

Acute lung injury (ALI) is common among critically ill patients and is associated with a high case fatality. Only one intervention has been shown to improve survival in a large clinical trial, and new therapies targeting the inflammatory response are needed. Nutrient interventions may provide benefit; specifically there is plausible biologic rationale for administering n-3 fatty acids (n-3 FAs) found in fish oil to patients with ALI, as n-3 FAs decrease formation of eicosanoid inflammatory mediators. However, although promising results have emerged from prior studies, fish oils have only been tested in ALI patients in a commercial enteral formula containing additional nutrients, and the control group received a high-fat enteral formula that may have been proinflammatory. Therefore, no conclusion can be drawn about the independent effect of fish oils. Furthermore, the inclusion of key pharmaconutrients in feeding formulas, instead of delivering them separately as pharmaceuticals, limits exposure to the agent, as intensive care unit (ICU) patients commonly receive less than 60% of prescribed caloric needs. Finally, specialized feeding formulas are very expensive, and it may be substantially cheaper to administer pharmaconutrients separately. We believe it is time to begin to approach nutrient trials in critically ill patients differently -- to move away from including them in feeding formulas and begin delivering them like pharmaceuticals. With appropriate scientific investigation and the use of non-nutrient placebos, this novel and innovative approach is a new paradigm of investigating nutrient delivery to critically ill patients.

This study is a phase II randomized controlled trial to determine the effects of enteral eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA), both n-3 FAs found in fish oil, versus placebo on the pulmonary and systemic environments, and on clinical outcomes, in patients with ALI. We will investigate the effect of fish oil administration on several biological markers of injury and inflammation in bronchoalveolar lavage fluid and serum, on pulmonary physiologic outcomes, and on clinical outcomes.

Comparison(s): Mechanically ventilated patients with acute lung injury randomized to receive enteral fish oil versus compared to mechanically ventilated patients with acute lung injury randomized to receive placebo.

Conditions

Respiratory Distress Syndrome, Adult; Acute Lung Injury; Acute Respiratory Distress Syndrome

Study Design

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

Study Groups

1

Enteral fish oil

Group Type: EXPERIMENTAL

Fish oil (eicosapentaenoic acid and docosahexanoic acid)

Intervention Type: DRUG

Liquid fish oil 7.5cc enterally every 6 hours

2

Enteral saline

Group Type: PLACEBO_COMPARATOR

Fish oil (eicosapentaenoic acid and docosahexanoic acid)

Intervention Type: DRUG

Liquid fish oil 7.5cc enterally every 6 hours

Interventions

Fish oil (eicosapentaenoic acid and docosahexanoic acid)

Liquid fish oil 7.5cc enterally every 6 hours

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Requiring positive-pressure mechanical ventilation
• ALI criteria: PaO2/FiO2 <300, bilateral infiltrates on chest radiograph, no left atrial hypertension
• Age > 17 years

Exclusion Criteria

• Expected ICU length of stay <48 hours
• Unable to undergo bronchoalveolar lavage at enrollment
• Unable to obtain enteral access
• Post-cardiac arrest with suspected significant anoxic brain injury
• Expected survival < 28 days
• Pregnant
• Platelet count < 30,000, active bleeding, or international normalized ratio (INR)>3.0
• History of ventricular tachycardia or fibrillation
• Receiving recombinant human activated protein C (rh-APC) for sepsis
• Acquired immune deficiency syndrome (AIDS) with CD4 count < 200
• Metastatic cancer
• History of bone marrow, lung, liver, cardiac, kidney, or pancreas transplant

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

American Thoracic Society

OTHER

Sponsor Role: collaborator

Acute Respiratory Distress Syndrome Foundation

OTHER

Sponsor Role: collaborator

American Society for Parenteral and Enteral Nutrition

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Renee Stapleton

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renee D. Stapleton, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

St. Alphonsus Medical Center

Boise, Idaho, United States

Oregon Health Sciences University

Portland, Oregon, United States

University of Vermont/Fletcher Allen Health Care

Burlington, Vermont, United States

Harborview Medical Center

Seattle, Washington, United States

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

05-7895-A 03

Identifier Type: -

Identifier Source: secondary_id

28503-A

Identifier Type: -

Identifier Source: org_study_id