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The National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network*. Initial Trophic vs Full Enteral Feeding in Patients With Acute Lung Injury: The EDEN Randomized Trial. JAMA. 2012;307(8):795–803. doi:https://doi.org/10.1001/jama.2012.137
*The National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network Writing Committee: The following individuals take authorship responsibility for the EDEN study results: Todd W. Rice, MD, MSc, Vanderbilt University School of Medicine, Nashville, Tennessee; Arthur P. Wheeler, MD, Vanderbilt University School of Medicine; B. Taylor Thompson, MD, Massachusetts General Hospital, Boston; Jay Steingrub, MD, Baystate Medical Center, Springfield, Massachusetts; R. Duncan Hite, MD, Wake Forest School of Medicine, Winston-Salem, North Carolina; Marc Moss, MD, University of Colorado School of Medicine, Denver; Alan Morris, MD, University of Utah School of Medicine, Salt Lake City; Ning Dong, MS, Massachusetts General Hospital; Peter Rock, MD, MBA, University of Maryland School of Medicine, Baltimore.
Context The amount of enteral nutrition patients with acute lung injury need is unknown.
Objective To determine if initial lower-volume trophic enteral feeding would increase ventilator-free days and decrease gastrointestinal intolerances compared with initial full enteral feeding.
Design, Setting, and Participants The EDEN study, a randomized, open-label, multicenter trial conducted from January 2, 2008, through April 12, 2011. Participants were 1000 adults within 48 hours of developing acute lung injury requiring mechanical ventilation whose physicians intended to start enteral nutrition at 44 hospitals in the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network.
Interventions Participants were randomized to receive either trophic or full enteral feeding for the first 6 days. After day 6, the care of all patients who were still receiving mechanical ventilation was managed according to the full feeding protocol.
Main Outcome Measures Ventilator-free days to study day 28.
Baseline characteristics were similar between the trophic-feeding (n = 508) and full-feeding (n = 492) groups. The full-feeding group received more enteral calories for the first 6 days, about 1300 kcal/d compared with 400 kcal/d (P < .001). Initial trophic feeding did not increase the number of ventilator-free days (14.9 [95% CI, 13.9 to 15.8] vs 15.0 [95% CI, 14.1 to 15.9]; difference, −0.1 [95% CI, −1.4 to 1.2]; P = .89) or reduce 60-day mortality (23.2% [95% CI, 19.6% to 26.9%] vs 22.2% [95% CI, 18.5% to 25.8%]; difference, 1.0% [95% CI, −4.1% to 6.3%]; P = .77) compared with full feeding. There were no differences in infectious complications between the groups. Despite receiving more prokinetic agents, the full-feeding group experienced more vomiting (2.2% vs 1.7% of patient feeding days; P = .05), elevated gastric residual volumes (4.9% vs 2.2% of feeding days; P < .001), and constipation (3.1% vs 2.1% of feeding days; P = .003). Mean plasma glucose values and average hourly insulin administration were both higher in the full-feeding group over the first 6 days.
Conclusion In patients with acute lung injury, compared with full enteral feeding, a strategy of initial trophic enteral feeding for up to 6 days did not improve ventilator-free days, 60-day mortality, or infectious complications but was associated with less gastrointestinal intolerance.
clinicaltrials.gov Identifiers: NCT00609180 and NCT00883948
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