Early Versus Delayed Enteral Feeding to Treat People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN Study)

Completed · Phase 3

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 remain 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.

Key facts

Study ID: NCT00883948
Run by: National Heart, Lung, and Blood Institute (NHLBI)
People needed: 1000
Starts: 2007-12-01
Expected to finish: 2011-05-01
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 within a 24-hour period of study entry: 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 other inclusion criteria

You may not qualify if…

Neuromuscular disease that impairs ability to breathe 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
Cancer 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 in 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 long-term 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 after study entry
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
University of California, San Francisco (UCSF)-Moffitt 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
Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
Johns Hopkins Hospital — Baltimore, Maryland, United States
Union Memorial 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
Duke University Medical Center — Durham, North Carolina, United States
Durham Regional Medical Center — Durham, North Carolina, United States
Moses Cone Health System — Greensboro, North Carolina, United States

Full record on ClinicalTrials.gov

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