Early Versus Delayed Enteral Feeding to Treat People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN Study)
EDEN
Prospective, Randomized, Multi-Center Trial of Initial Trophic Enteral Feeding Followed by Advancement to Full-Calorie Enteral Feeding vs. Early Advancement to Full-Calorie Enteral Feeding in Patients With Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS)
3 other identifiers
interventional
1,000
1 country
39
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2007
Typical duration for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 17, 2009
CompletedFirst Posted
Study publicly available on registry
April 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedApril 13, 2016
February 1, 2012
3.2 years
April 17, 2009
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of ventilator-free days (VFD)
Measured at Day 28
Mortality before hospital discharge, with unassisted breathing
Measured at Days 60 and 90
Secondary Outcomes (8)
Number of intensive care unit-free days
Measured at Day 28
Number of organ failure-free days (liver, kidney, heart, central nervous system, and hematologic)
Measured at Day 28
Incidence of ventilator-associated pneumonia
Measured at Day 28
Number of days from first meeting criteria for weaning readiness to Day 28
Measured at Day 28
VFDs and mortality in participants with a partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FIO2) less than or equal to 200 or with shock at the time of study entry
Measured at Days 28 and 60, respectively
- +3 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALParticipants will receive initial minimal (trophic) enteral feeding.
2
EXPERIMENTALParticipants will receive initial full-calorie enteral feeding.
Interventions
Upon admission to the ICU, enteral feeds will be started at 10 cc per hour and continued at this rate for 144 hours. After 144 hours of trophic enteral feeds, the feeding rate will be advanced to full-calorie rates, which will continue for the duration of mechanical ventilation up to Day 28.
Upon admission to the ICU, a full-calorie feeding rate will be determined, which will be calculated to deliver 25 to 35 kcal/kg predicted body weight (PBW) each day. Enteral feeds will be initiated at 25 cc per hour. The feeding rate will be increased by 25 cc per hour every 6 hours until goal rate is achieved, which will be administered for the duration of mechanical ventilation up to Day 28.
Eligibility Criteria
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
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)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
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
Wesley Long Community Hospital
Greensboro, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital
Ogden, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Related Publications (2)
Brown SM, Wilson E, Presson AP, Zhang C, Dinglas VD, Greene T, Hopkins RO, Needham DM; with the National Institutes of Health NHLBI ARDS Network. Predictors of 6-month health utility outcomes in survivors of acute respiratory distress syndrome. Thorax. 2017 Apr;72(4):311-317. doi: 10.1136/thoraxjnl-2016-208560. Epub 2016 Jul 20.
PMID: 27440140DERIVEDNational Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
PMID: 22307571DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Arthur P. Wheeler, MD
Vanderbilt University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2009
First Posted
April 20, 2009
Study Start
December 1, 2007
Primary Completion
March 1, 2011
Study Completion
May 1, 2011
Last Updated
April 13, 2016
Record last verified: 2012-02