A Phase 3 interventional study of Minimal (Trophic) Feeding and Full Feeding in Respiratory Distress Syndrome, Adult, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Terminated at 41 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2016-04-13.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Phase 3, Interventional, and Treatment
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.
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 sign measurements, blood draws, a frontal chest radiograph, ventilator settings, and placement of feeding tube. Participants will be randomly assigned to receive initial enteral feedings that are either minimal (trophic) or full-calorie. They will also be randomly assigned to receive either omega-3 fatty acid and antioxidant supplementation or placebo. 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 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. Omega-3 fatty acid, antioxidant, and placebo supplements will be administered with a syringe into the participant's feeding tube every 12 hours until Day 21 or discontinuation of the ventilator.
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 272 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.
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Exclusion Criteria:
Participants will receive initial minimal (trophic) enteral feeding and the omega-3 fatty acid and anti-oxidant supplements
Behavioral: Minimal (Trophic) Feeding · Dietary Supplement: Omega-3 Fatty Acids and Antioxidant Supplements
Participants will receive initial full-calorie enteral feeding and the omega-3 fatty acid and anti-oxidant supplements
Behavioral: Full Feeding · Dietary Supplement: Omega-3 Fatty Acids and Antioxidant Supplements
Participants will receive initial minimal (trophic) enteral feeding and the placebo supplement
Behavioral: Minimal (Trophic) Feeding · Dietary Supplement: Placebo
Participants will receive initial full-calorie enteral feeding and the placebo supplement
Behavioral: Full Feeding · Dietary Supplement: Placebo
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.
Omega-3 fatty acids, GLA, and antioxidants will be administered through a feeding tube every 12 hours as a 120-cc bolus. Dosing will continue for 21 days or until discontinuation of mechanical ventilation.
The study placebo will be administered through a feeding tube every 12 hours as a 120 cc bolus. Dosing will continue for 21 days or until discontinuation of mechanical ventilation.
Also known as: TwoCal
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
This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
National Heart, Lung, and Blood Institute (NHLBI)