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


METHODS
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.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
clinicaltrials.gov Identifiers: NCT00609180 and NCT00883948.
Todd W
TW
Rice
Arthur P
AP
Wheeler
B Taylor
BT
Thompson
Jay
J
Steingrub
R Duncan
RD
Hite
Marc
M
Moss
Alan
A
Morris
Ning
N
Dong
Peter
P
Rock
D055371:Acute Lung Injury / Q000401:mortality / Q000628:therapy; D000328:Adult; D000368:Aged; D002149:Energy Intake; D004750:Enteral Nutrition / Q000009:adverse effects / Q000379:methods*; D005260:Female; D041981:Gastrointestinal Tract / Q000503:physiopathology; D006801:Humans; D007239:Infections / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012121:Respiration, Artificial; D013997:Time Factors; D016896:Treatment Outcome