Dataset Information

One year outcomes in patients with acute lung injury randomised to initial trophic or full enteral feeding: prospective follow-up of EDEN randomised trial.

ABSTRACT:

Objective

To evaluate the effect of initial low energy permissive underfeeding ("trophic feeding") versus full energy enteral feeding ("full feeding") on physical function and secondary outcomes in patients with acute lung injury.

Design

Prospective longitudinal follow-up evaluation of the NHLBI ARDS Clinical Trials Network's EDEN trial

Setting

41hospitals in the United States.

Participants

525 patients with acute lung injury.

Interventions

Randomised assignment to trophic or full feeding for up to six days; thereafter, all patients still receiving mechanical ventilation received full feeding.

Measurements

Blinded assessment of the age and sex adjusted physical function domain of the SF-36 instrument at 12 months after acute lung injury. Secondary outcome measures included survival; physical, psychological, and cognitive functioning; quality of life; and employment status at six and 12 months.

Results

After acute lung injury, patients had substantial physical, psychological, and cognitive impairments, reduced quality of life, and impaired return to work. Initial trophic versus full feeding did not affect mean SF-36 physical function at 12 months (55 (SD 33) v 55 (31), P=0.54), survival to 12 months (65% v 63%, P=0.63), or nearly all of the secondary outcomes.

Conclusion

In survivors of acute lung injury, there was no difference in physical function, survival, or multiple secondary outcomes at 6 and 12 month follow-up after initial trophic or full enteral feeding.

Trial registration

NCT No 00719446.

SUBMITTER: Needham DM

PROVIDER: S-EPMC3601941 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.

Project description:ObjectiveEnteral 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.DesignRandomized, open-label study.PatientsA total of 200 patients with acute respiratory failure expected to require mechanical ventilation for at least 72 hrs.InterventionsPatients were randomized to receive either initial trophic (10 mL/hr) or full-energy enteral nutrition for the initial 6 days of ventilation.Measurements and main resultsThe 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).ConclusionInitial 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.