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

ABSTRACT: 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.clinicaltrials.gov Identifiers: NCT00609180 and NCT00883948.

SUBMITTER: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network

PROVIDER: S-EPMC3743415 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature

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

Rice Todd W TW Wheeler Arthur P AP Thompson B Taylor BT Steingrub Jay J Hite R Duncan RD Moss Marc M Morris Alan A Dong Ning N Rock Peter P

JAMA 20120205 8

<h4>Context</h4>The amount of enteral nutrition patients with acute lung injury need is unknown.<h4>Objective</h4>To determine if initial lower-volume trophic enteral feeding would increase ventilator-free days and decrease gastrointestinal intolerances compared with initial full enteral feeding.<h4>Design, setting, and participants</h4>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 ...[more]

PMID: 22307571

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Project description:Enteral nutrition is provided to mechanically ventilated patients who cannot eat normally, yet the amount of support needed is unknown. We conducted this randomized, open-label study to test the hypothesis that initial low-volume (i.e., trophic) enteral nutrition would decrease episodes of gastrointestinal intolerance/complications and improve outcomes as compared to initial full-energy enteral nutrition in patients with acute respiratory failure.Randomized, open-label study.A total of 200 patients with acute respiratory failure expected to require mechanical ventilation for at least 72 hrs.Patients were randomized to receive either initial trophic (10 mL/hr) or full-energy enteral nutrition for the initial 6 days of ventilation.The primary outcome measure was ventilator-free days to day 28. Baseline characteristics were similar between the 98 patients randomized to trophic and the 102 patients randomized to full-energy nutrition. At enrollment, patients had a mean Acute Physiology and Chronic Health Evaluation II score of 26.9 and a PaO2/FiO2 ratio of 182 and 38% were in shock. Both groups received similar durations of enteral nutrition (5.5 vs. 5.1 days; p = .51). The trophic group received an average of 15.8% ± 11% of goal calories daily through day 6 compared to 74.8% ± 38.5% (p < .001) for the full-energy group. Both groups had a median of 23.0 ventilator-free days (p = .90) and a median of 21.0 intensive-care-unit-free days (p = .64). Mortality to hospital discharge was 22.4% for the trophic group vs. 19.6% for the full-energy group (p = .62). In the first 6 days, the trophic group had trends for less diarrhea (19% vs. 24% of feeding days; p = .08) and significantly fewer episodes of elevated gastric residual volumes (2% vs. 8% of feeding days; p < .001).Initial trophic enteral nutrition resulted in clinical outcomes in mechanically ventilated patients with acute respiratory failure similar to those of early full-energy enteral nutrition but with fewer episodes of gastrointestinal intolerance.

Project description:ContextThe omega-3 (n-3) fatty acids docosahexaenoic acid and eicosapentaenoic acid, along with γ-linolenic acid and antioxidants, may modulate systemic inflammatory response and improve oxygenation and outcomes in patients with acute lung injury.ObjectiveTo determine if dietary supplementation of these substances to patients with acute lung injury would increase ventilator-free days to study day 28.Design, setting, and participantsThe OMEGA study, a randomized, double-blind, placebo-controlled, multicenter trial conducted from January 2, 2008, through February 21, 2009. Participants were 272 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. All participants had complete follow-up.InterventionsTwice-daily enteral supplementation of n-3 fatty acids, γ-linolenic acid, and antioxidants compared with an isocaloric control. Enteral nutrition, directed by a protocol, was delivered separately from the study supplement.Main outcome measureVentilator-free days to study day 28.ResultsThe study was stopped early for futility after 143 and 129 patients were enrolled in the n-3 and control groups. Despite an 8-fold increase in plasma eicosapentaenoic acid levels, patients receiving the n-3 supplement had fewer ventilator-free days (14.0 vs 17.2; P = .02) (difference, -3.2 [95% CI, -5.8 to -0.7]) and intensive care unit-free days (14.0 vs 16.7; P = .04). Patients in the n-3 group also had fewer nonpulmonary organ failure-free days (12.3 vs 15.5; P = .02). Sixty-day hospital mortality was 26.6% in the n-3 group vs 16.3% in the control group (P = .054), and adjusted 60-day mortality was 25.1% and 17.6% in the n-3 and control groups, respectively (P = .11). Use of the n-3 supplement resulted in more days with diarrhea (29% vs 21%; P = .001).ConclusionsTwice-daily enteral supplementation of n-3 fatty acids, γ-linolenic acid, and antioxidants did not improve the primary end point of ventilator-free days or other clinical outcomes in patients with acute lung injury and may be harmful.Trial registrationclinicaltrials.gov Identifier: NCT00609180.

Project description:BackgroundIntestinal mucosal barrier injury and gastrointestinal dysfunction are important causes of sepsis. However, few studies have investigated the effects of enteral underfeeding on gastrointestinal function in sepsis. Moreover, no consensus on goal enteral caloric intake has been reached in sepsis.AimTo investigate the effects of different goal caloric requirements of enteral nutrition on the gastrointestinal function and outcomes in the acute phase of sepsis.MethodsPatients were randomly assigned to receive 30% (defined as group A), 60% (group B), or 100% (group C) of goal caloric requirements of enteral nutrition in this prospective pilot clinical trial. The acute gastrointestinal injury (AGI) grades, incidence of feeding intolerance (FI), daily caloric intake, nutritional and inflammatory markers, and biomarkers of mucosal barrier function were collected during the first 7 d of enteral feeding. The clinical severity and outcome variables were also recorded.ResultsA total of 54 septic patients were enrolled. The days to goal calorie of group C (2.55 ± 0.82) were significantly longer than those of group A (3.50 ± 1.51; P = 0.046) or B (4.85 ± 1.68; P < 0.001). The FI incidence of group C (16.5%) was higher than that of group A (5.0%) or B (8.7%) (P = 0.009). No difference in the incidence of FI symptoms was found between groups A and B. The serum levels of barrier function biomarkers of group B were significantly lower than those of group A (P < 0.05) on the 7th day of feeding. The prealbumin and IL-6 levels of group A were lower than those of group B (P < 0.05) on the 7th day of feeding. No significant differences in the clinical outcome variables or 28-d mortality were found among the three groups.ConclusionEarly moderate enteral underfeeding (60% of goal requirements) could improve the intestinal barrier function and nutritional and inflammatory status without increasing the incidence of FI symptoms in sepsis. However, further large-scale prospective clinical trials and animal studies are required to test our findings. Moreover, the effects of different protein intake on gastrointestinal function and outcomes should also be investigated in future work.

Dataset Information

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

Publications

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

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