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)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Respiratory Distress Syndrome, Adult

In brief

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 the lungs to function properly. Hospital treatment for a person with ALI/ARDS often includes the use of a breathing machine, or ventilator, until the person is able to breathe without assistance. Initiating proper nutrition through a feeding tube early in a person's hospital stay may help to improve recovery, but the optimal timing, composition, and amount of feeding treatments are unknown. This study will evaluate whether early or delayed full-calorie feeding through a feeding tube is more effective in reducing recovery time and increasing survival rates in people with ALI/ARDS. The study will also determine whether supplementing the feedings with omega-3 fatty acids and antioxidants benefits people with ALI/ARDS.

Key facts

Study ID

NCT00609180

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

272

Starts

2007-12-01

Expected to finish

2009-04-01

Last updated by the study team

2016-04-13

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of San Francisco-Fresno Medical Center — Fresno, California, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• UCSF-Moffitt Hospital — San Francisco, California, United States
• UCSF-San Francisco General Hospital — San Francisco, California, United States
• Centura St. Anthony Central Hospital — Denver, Colorado, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Baton Rouge General Hospital-Blue Bonnet — Baton Rouge, Louisiana, United States
• Baton Rouge General Hospital-Midcity — Baton Rouge, Louisiana, United States
• Earl K. Long Medical Center — Baton Rouge, Louisiana, United States
• Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States
• Medical Center of Louisiana — New Orleans, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Baltimore VA Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Maryland Shock Trauma Center — Baltimore, Maryland, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Rochester Methodist Hospital — Rochester, Minnesota, United States
• St. Mary's Hospital, Mayo Clinic — Rochester, Minnesota, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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