Status:
TERMINATED
Early Versus Delayed Enteral Feeding and Omega-3 Fatty Acid/Antioxidant Supplementation for Treating People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN-Omega Study)
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief Summary
Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions that occur when there is severe inflammation and increased fluids in both lungs, making it difficult for t...
Detailed Description
ALI/ARDS involves extensive inflammation in the lungs that can lead to rapid respiratory failure. These conditions are most commonly caused by pneumonia, generalized infection, or severe trauma to the...
Eligibility Criteria
Inclusion
- Must meet the following three criteria at study entry within a 24-hour period: 1) PaO2/FiO2 less than or equal to 300 (if altitude is more than 1000 meters, then PaO2/FiO2 less than or equal to 300 x \[barometric pressure/760\]), 2) bilateral infiltrates (patchy, diffuse, homogeneous, or asymmetric) consistent with pulmonary edema on frontal chest radiograph, and 3) requirement for positive pressure ventilation via endotracheal tube
- No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates
- Intention of primary medical team to enterally feed the patient
- Undergoes enteral feeding within 48 hours of meeting inclusion criteria
Exclusion
- Neuromuscular disease that impairs ability to breath without assistance, such as cervical spinal cord injury at level C5 or higher, amyotrophic lateral sclerosis, Guillain-Barré syndrome, or myasthenia gravis
- Pregnant or breastfeeding
- Severe chronic respiratory disease. More information about this criterion can be found in the protocol.
- Burns on greater than 40% total body surface area
- Malignancy or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%. More information about this criterion can be found in the protocol.
- Allogeneic bone marrow transplant within the 5 years before study entry
- Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
- Severe chronic liver disease (Child-Pugh score of 11 to 15)
- Diffuse alveolar hemorrhage from vasculitis
- Morbid obesity, defined as 1 kg/cm body weight
- Unwilling or unable to use the ARDS network 6 mL/kg PBW ventilation protocol
- Moribund patient not expected to survive 24 hours
- No intent to obtain central venous access for monitoring intravascular pressures
- More than 72 hours since mechanical ventilation initiated
- Refractory shock. More information about this criterion can be found in the protocol.
- Unable to obtain enteral access
- Presence of partial or complete mechanical bowel obstruction
- Presence of ischemia or infarction
- Current total parenteral nutrition (TPN) use or intent to use TPN within 7 days of study entry
- Severe malnutrition with body mass index less than 18.5 or loss of more than 30% total body weight in the 6 months before study entry
- Laparotomy expected within 7 days of study entry
- Unable to raise head of bed 30 to 45 degrees
- Short-bowel syndrome or absence of gastrointestinal tract
- Presence of high-output (greater than 500 cc/day) enterocutaneous fistula
- International normalized ratio greater than 5.0, platelet count less than 30,000/mm3, or history of bleeding disorder
- Intracranial hemorrhage within the 1 month before study entry
- Allergy to enteral formula, omega-3 fatty acids, GLA, vitamin E, vitamin C, beta-carotene, taurine, or L-carnitine
- Requirement for, or physician insistence on, enteral formula supplemented with omega-3 fatty acids (ex: Oxepa®, Impact®) or providing omega-3 fatty acid, GLA, or antioxidant supplementation
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT00609180
Start Date
December 1 2007
End Date
April 1 2009
Last Update
April 13 2016
Active Locations (41)
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1
University of San Francisco-Fresno Medical Center
Fresno, California, United States
2
University of California, Davis Medical Center
Sacramento, California, United States
3
UCSF-Moffitt Hospital
San Francisco, California, United States
4
UCSF-San Francisco General Hospital
San Francisco, California, United States