Initial Trophic vs Full Enteral Feeding in Patients With Acute Lung Injury: The EDEN Randomized Trial

JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 02/2012; 307(8):795-803. DOI: 10.1001/jama.2012.137
Source: PubMed


The amount of enteral nutrition patients with acute lung injury need is unknown.
To determine if initial lower-volume trophic enteral feeding would increase ventilator-free days and decrease gastrointestinal intolerances compared with initial full enteral feeding.
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.
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.
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.
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. Identifiers: NCT00609180 and NCT00883948.

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    • "However, despite the above guidelines, there is also concern that the administration of energy at such levels in critically ill patients may not be advantageous [5]. Some investigators have shown that low calorie nutrition alone may be sufficient [6] or even desirable [7]. "
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    ABSTRACT: Current practice in the delivery of caloric intake (DCI) in patients with severe acute kidney injury (AKI) receiving renal replacement therapy (RRT) is unknown. We aimed to describe calorie administration in patients enrolled in the Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study and to assess the association between DCI and clinical outcomes. We performed a secondary analysis in 1456 patients from the RENAL trial. We measured the dose and evolution of DCI during treatment and analyzed its association with major clinical outcomes using multivariable logistic regression, Cox proportional hazards models, and time adjusted models. Overall, mean DCI during treatment in ICU was low at only 10.9 +/- 9 Kcal/kg/day for non-survivors and 11 +/- 9 Kcal/kg/day for survivors. Among patients with a lower DCI (below the median) 334 of 729 (45.8%) had died at 90-days after randomization compared with 316 of 727 (43.3%) patients with a higher DCI (above the median) (P = 0.34). On multivariable logistic regression analysis, mean DCI carried an odds ratio of 0.95 (95% confidence interval (CI): 0.91-1.00; P = 0.06) per 100 Kcal increase for 90-day mortality. DCI was not associated with significant differences in renal replacement (RRT) free days, mechanical ventilation free days, ICU free days and hospital free days. These findings remained essentially unaltered after time adjusted analysis and Cox proportional hazards modeling. In the RENAL study, mean DCI was low. Within the limits of such low caloric intake, greater DCI was not associated with improved clinical outcomes.Trial registration: number, NCT00221013.
    Full-text · Article · Mar 2014 · Critical care (London, England)
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    • "Limiter plus que corriger complètement ce déficit énergétique précoce constitue probablement la stratégie d'assistance nutritionnelle la plus raisonnable [2] [23]. En effet, sur-ou sous-compenser les besoins énergétiques de façon excessive majore le risque de complications [24] [25] [26] [27]. "

    Full-text · Article · Feb 2014 · Annales francaises d'anesthesie et de reanimation
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    • "Three recent large studies [13-15] have compared full enteral feeding to intentional underfeeding or trophic nutrition, that is provision of small volume EN aiming to produce positive local effects on gastrointestinal mucosa and beneficial systemic effects [16]. None of these studies showed an effect on mortality [13-15]. Based on these studies, the updated Surviving Sepsis Campaign guidelines [17] suggest to avoid mandatory full caloric feeding but use low-dose enteral feeding in the first week of ICU stay (evidence grade 2B). "
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    ABSTRACT: Current international sepsis guidelines recommend low dose enteral nutrition (EN) for the first week. This contradicts other nutrition guidelines for heterogenous groups of ICU patients. Data on the optimal dose of EN in septic patients are lacking. Our aim was to evaluate the effect of energy and protein amount given by EN on clinical outcomes in a large cohort of critically ill septic patients. We conducted a secondary analysis of pooled data collected prospectively from international nutrition studies. Eligible patients had a diagnosis of sepsis and/or pneumonia and were admitted to the ICU for >= 3 days, mechanically ventilated within 48 hours of ICU admission and only receiving EN. Patients receiving parenteral nutrition were excluded. Data were collected from ICU admission up to a maximum of 12 days. Regression models were used to examine the impact of calorie and protein intake on 60-day mortality and ventilator-free days. Of the 13,630 patients included in the dataset, 2,270 met the study inclusion criteria. Patients received a mean amount of 1,057 kcal/d (14.5 kcal/kg/day) and 49 g protein/day (0.7 g/kg/d) by EN alone. 60-day mortality was 30.5% and patients were mechanically ventilated for median 8.4 days. An increase of 1,000 kcal was associated with reduced 60-day mortality (odds ratio (OR) 0.61; 95% confidence interval (CI) 0.48-0.77, P < 0.001) and more ventilator-free days (2.81 days, 95% CI 0.53-5.08, P = 0.02) as was an increase of 30 g protein per day (OR 0.76; 95% CI 0.65-0.87, P < 0.001 and 1.92 days, 95% CI 0.58-3.27, P = 0.005, respectively). In critically ill septic patients, a calorie and protein delivery closer to recommended amounts by EN in the early phase of ICU stay was associated with a more favorable outcome.
    Full-text · Article · Feb 2014 · Critical care (London, England)
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