Therapy Initial Tropic vs Full Enteral Feeding in Patients with Acute Lung Injury The EDEN Randomized Trial
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Summary
Posted By:	Elizabeth Sweetman
E-Mail:	esweetman@med.usyd.edu.au
Posted Date:	16.03.12
Title:	Initial Tropic vs Full Enteral Feeding in Patients with Acute Lung Injury The EDEN Randomized Trial
Authors:	National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network, Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P.
Reference:	JAMA 2012; 307 (8): 795 - 803.
Link:	Click here for a direct link to the paper. A password may be required for access to fulltext.
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.
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? ( Was allocation concealment maintained?)
	Yes. Participants were randomized via a web based randomization system. Patients were randomised to receive either tropic or full enteral feeding for the first 6 days of mechanical ventilation.
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
	Yes follow-up was complete for the primary outcome (See Table 2).
2b. Were patients analyzed in the groups to which they were randomized?
	Yes patients were analysed in the groups to which they were randomised.
3. Were patients, health workers, and study personnel blind to treatment?
	No. This RCT was unblinded.
4. Were the groups similar at the start of the trial?
	Yes as per Table 1. The authors did not provide P values in this table.
5. Aside from the experimental intervention, were the groups treated equally?
	Yes. Patients allocated in the full fed group received more fluid in the first 6 days from point of randomisation and also received more prokinetic agents.
What are the Results?
1. How large was the treatment effect?
	Tropic-Feeding Group vs Full-Feeding Group Primary Outcomes: Ventilator Free Days (VFDs)to Day 28 14.9 (95% CI 13.9 to 15.8) vs 15.0 (95% CI 14.1 to 15.9); P = 0.89 Secondary Outcomes: 60 Day Mortality (%) 23.2% (95% CI 19.6 to 26.9) vs 22.2% (95% CI 18.5 to 25.8); P = 0.77 Development of infections VAP 7.3% (95% CI 5.0 - 9.5)vs 6.7% (95% CT 4.5 - 8.9); P = 0.72 Vomiting 1.7% vs 2.2% of Patient Days; P= 0.05 Elevated Gastric Residual Volumes 2.2% vs 4.9% of Feeding Days; P= <0.01 Constipation 2.1% vs 3.1% of Feeding Days; P= 0.03
2. How precise was the estimate of the treatment effect?
	See above for 95% Confidence Intervals around the absolute risk differences.
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
	Yes. EN delivery in Australia is variable, some ICUs initiate EN at higher rates and aim to reach EN goals quickly, other units start EN at lower rates and gradually increase over a longer time frame. This trial does provide important safety information for both methods.
2. Were all clinically important outcomes considered?
	Yes. The authors may have considered including longer term quality of life and physical function measures.
3. Are the likely treatment benefits worth the potential harms and costs?
	There were no benefits or harms between study groups. Clinicians must keep in mind that whilst over a 6 Day time frame the Full Feeding group received more EN calories, they also experienced a significantly higher incidence of vomiting, elevated gastric residuals and constipation than the Trophic Group.
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