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

NCT00883948 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2016-04-13

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Arthur P. Wheeler, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2011-03-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00883948 on ClinicalTrials.gov