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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

March 31, 2011

Study Completion Date

May 31, 2011

Conditions
Respiratory Distress Syndrome, Adult
Interventions
BEHAVIORAL

Minimal (Trophic) Feeding

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.

BEHAVIORAL

Full Feeding

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.

Trial Locations (39)

Unknown

University of San Francisco-Fresno Medical Center, Fresno

University of California, Davis Medical Center, Sacramento

University of California, San Francisco (UCSF)-Moffitt Hospital, San Francisco

Centura St. Anthony Central Hospital, Denver

Denver Health Medical Center, Denver

Rose Medical Center, Denver

University of Colorado Health Sciences Center, Denver

Washington Hospital Center, Washington D.C.

Baton Rouge General Hospital-Blue Bonnet, Baton Rouge

Baton Rouge General Hospital-Midcity, Baton Rouge

Earl K. Long Medical Center, Baton Rouge

Our Lady of the Lake Regional Medical Center, Baton Rouge

Medical Center of Louisiana, New Orleans

Ochsner Clinic Foundation, New Orleans

Tulane University Health Sciences Center, New Orleans

Johns Hopkins Bayview Medical Center, Baltimore

Johns Hopkins Hospital, Baltimore

Union Memorial Hospital, Baltimore

University of Maryland Shock Trauma Center, Baltimore

Baystate Medical Center, Springfield

Rochester Methodist Hospital, Rochester

St. Mary's Hospital, Mayo Clinic, Rochester

Duke University Medical Center, Durham

Durham Regional Medical Center, Durham

Moses Cone Health System, Greensboro

Wesley Long Community Hospital, Greensboro

Wake Forest University Baptist Medical Center, Winston-Salem

Cleveland Clinic Foundation, Cleveland

MetroHealth Medical Center, Cleveland

University Hospitals of Cleveland, Cleveland

Vanderbilt University Medical Center, Nashville

Baylor College of Medicine, Houston

Intermountain Medical Center, Murray

McKay-Dee Hospital, Ogden

Utah Valley Regional Medical Center, Provo

LDS Hospital, Salt Lake City

University of Virginia Medical Center, Charlottesville

Harborview Medical Center, Seattle

University of Washington, Seattle

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH

NCT00883948 - Early Versus Delayed Enteral Feeding to Treat People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN Study) | Biotech Hunter | Biotech Hunter