Clinical Trial: Early Versus Delayed Enteral Feeding and Omega-3 Fatty Acid/Antioxidant Supplementation for Treating People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN-Omega Study)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 are 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. The study will also determine whether supplementing the feedings with omega-3 fatty acids and antioxidants benefits people with ALI/ARDS.

Detailed Summary:

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, compared to delayed feeding, enteral feeding initiated soon after a patient begins assisted breathing is associated with a shorter hospital stay and a better chance of survival. However, other studies show the opposite, and studies on optimal feeding volume and composition have conflicting results. Studies have also indicated that enhancing enteral feeding with omega-3 fatty acid and antioxidant supplements may help reduce lung inflammation, improving overall recovery rates. 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. The study will also determine whether supplementation with omega-3 fatty acid and antioxidants adds any beneficial effect.

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
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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 respecitvely ]
  • Change in plasma and mini-bronchoalveolar lavage (BAL) levels of interleukin (IL)-6, IL-8, von Willebrand factor (VWF), sufactant 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 ]


Information By: National Heart, Lung, and Blood Institute (NHLBI)

Dates:
Date Received: January 31, 2008
Date Started: December 2007
Date Completion:
Last Updated: April 12, 2016
Last Verified: February 2012