Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial.

JAMA

Feb 2012

DOI: 10.1001/jama.2012.137

Citations:829

Influential Citations:15

Interventional (Human) Studies

Enhanced Details

Methods

Randomized, open-label, multicenter trial enrolling 1000 adults (mean age ~52 years; about 47–51% women) with acute lung injury requiring mechanical ventilation, enrolled within 48 hours of ALI onset, at 44 hospitals in the NHLBI ARDS Clinical Trials Network.

Intervention

Initial trophic enteral feeding for 6 days: start within 6 hours of randomization at 10 mL/h (approximately 10–20 kcal/h). For the first 272 patients, concurrently receive omega-3 fatty acids and antioxidants as a supplement at 240 mL/day (OMEGA). After day 6, advance to full-energy enteral feeding if still ventilated, using the full-feeding protocol. Full-energy feeding: begin at 25 mL/h; targets 25–30 kcal/kg/day nonprotein calories and 1.2–1.6 g/kg/day protein. Gastric residual volumes checked every 6 hours; feed held per protocol for GI intolerance when GRV > 400 mL. Postpyloric tubes used in <20% of patients. No parenteral nutrition allowed. If trophic group remains ventilated at 144 hours (6 days), advance to full feeding per protocol.

Results

No difference in ventilator-free days to day 28 between trophic and full feeding (14.9 vs 15.0 days; P=0.89). 60-day mortality similar (23.2% vs 22.2%; P=0.77). Infectious complications similar. Gastrointestinal intolerance was reduced with trophic feeding: fewer days with regurgitation, vomiting, elevated gastric residual volumes, and constipation; trophic feeding also required fewer antidiarrheal and prokinetic medications. Full feeding increased total fluid intake and insulin use. Conclusion: Initial trophic enteral feeding for up to 6 days did not improve major clinical outcomes compared with full enteral feeding, but reduced gastrointestinal intolerance.

Limitations

Open-label design with potential reporting bias for GI intolerance; more frequent gastric residual volume checks in the full-feeding group; greater net fluid balance with full feeding could influence ventilator-free days; exclusion of underweight patients; generalizability limited to adults with ALI/ARDS in medical ICUs; did not assess safety of withholding feeding beyond 6 days or in non-ALI populations; parenteral nutrition was not allowed.

Abstract

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. RESULTS 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. TRIAL REGISTRATION clinicaltrials.gov Identifiers: NCT00609180 and NCT00883948. show less