Early Versus Delayed Enteral Feeding to Treat People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN Study) (EDEN)
|Respiratory Distress Syndrome, Adult||Behavioral: Minimal (Trophic) Feeding Behavioral: Full Feeding||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Number of ventilator-free days (VFD) [ Time Frame: Measured at Day 28 ]
- Mortality before hospital discharge, with unassisted breathing [ Time Frame: Measured at Days 60 and 90 ]
- Number of intensive care unit-free days [ Time Frame: Measured at Day 28 ]
- Number of organ failure-free days (liver, kidney, heart, central nervous system, and hematologic) [ Time Frame: Measured at Day 28 ]
- Incidence of ventilator-associated pneumonia [ Time Frame: Measured at Day 28 ]
- Number of days from first meeting criteria for weaning readiness to Day 28 [ Time Frame: 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 [ Time Frame: Measured at Days 28 and 60, respectively ]
- Change in plasma and mini-bronchoalveolar lavage (BAL) levels of interleukin (IL)-6, IL-8, von Willebrand factor (VWF), surfactant protein D (SPD), and total protein concentrations [ Time Frame: Measured at Day 3 ]
- Health-related quality of life; healthcare utilization; and psychological, neurocognitive, and physical activity outcomes [ Time Frame: Measured at Months 6 and 12 ]
- Duration of survival after hospital discharge using the National Death Index [ Time Frame: Measured at Months 6 and 12 ]
|Study Start Date:||December 2007|
|Study Completion Date:||May 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Participants will receive initial minimal (trophic) enteral feeding.
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.
Participants will receive initial full-calorie enteral feeding.
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.
ALI/ARDS involves extensive inflammation in the lungs that can lead to rapid respiratory failure. These conditions are most commonly caused by pneumonia, generalized infection, or severe trauma to the lungs, but can also be less commonly caused by smoke or salt water inhalation, drug overdose, or shock.
For some people, ALI/ARDS resolves without treatment, but many severe cases result in hospitalization in the intensive care unit (ICU), where 30% to 40% of cases end in mortality. Current treatments for ALI/ARDS include assisted breathing with a ventilator, supportive care, and management of the underlying causes. Enteral feeding, in which patients receive nutrition through a feeding tube, plays an important role in treatment, too. Some recent studies have shown that enteral feeding initiated soon after a patient begins assisted breathing is associated with a shorter hospital stay and a better chance of survival than delayed enteral feeding. However, other studies have shown the opposite, and studies on optimal feeding volume and composition have shown conflicting results. This study will evaluate the effects of early versus delayed full-calorie enteral feeding on mortality, ventilator-free days, ICU-free days, and organ failure in people with ALI/ARDS.
Upon admission to the ICU, a dietary evaluation will be done on each participant to determine goal, or full-calorie, feeding rates, which will be based on body weight and daily energy consumption. Participants will also undergo baseline assessments and procedures, which will include vital sign measurements, blood draws, a frontal chest radiograph, ventilator settings, and placement of a feeding tube. Participants will be randomly assigned to receive initial enteral feedings that are either minimal (trophic) or full-calorie. All participants will begin enteral feeding within 6 hours of treatment assignment.
Participants assigned to initial minimal enteral feedings will receive feedings at 10 cubic centimeters (cc) per hour, to be continued at this rate for 144 hours, provided that the participant remains on the ventilator. After the 144 hours, the feeding rate will be advanced to full-calorie rates.
Participants assigned to initial full-calorie enteral feedings will receive feedings at 25 cc per hour, and the feeding rate will be increased by 25 cc per hour every 6 hours until the goal rate is reached. During enteral feedings, gastric residual volumes (GRVs) will be checked every 6 to 12 hours to assure acceptable levels. Participants will complete enteral feedings upon hospital discharge, Day 28 of treatment, death, or ability to achieve 48 hours of unassisted breathing.
Blood pressure, heart rate, ventilation settings, and various blood factors will be measured during treatment. Phone-based follow-up assessments will occur at Months 6 and 12 after ICU discharge and will include measurements of health-related quality of life; psychological, neurocognitive, and physical activity outcomes; healthcare utilization; and mortality.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883948
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|Study Chair:||Arthur P. Wheeler, MD||Vanderbilt University Medical Center|