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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: Acute Respiratory Distress Syndrome Foundation; American Society for Parenteral and Enteral Nutrition; American Thoracic Society; National Heart, Lung, and Blood Institute (NHLBI)

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