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 trialSetting 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. MeasurementsBlinded 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. ConclusionIn 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 IntroductionOptimal nutritional strategies for mechanically ventilated patients in the intensive care unit are uncertain. There is some evidence and recommendations to support both initial full energy enteral feeding ("full feeding") and low energy permissive underfeeding ("trophic feeding") with different risks and benefits described. [1][2][3][4][5][6][7] The Acute Respiratory Distress Syndrome Clinical Trials Network of the National Heart, Lung and Blood Institute published a large, multicentre randomised open label trial of initial trophic compared with full enteral feeding for up to six days in patients with acute lung injury (the "EDEN trial"). 8 This trial found no significant difference in short term outcomes, including mortality and days without ventilation. Because nutritional interventions have the potential for longer term effects, 9 and because longer term outcomes of patients in intensive care units might differ from short term results, study outcomes also should be assessed over a longer time frame. 10-15Evaluation of longer term functional outcomes is especially important in patients with acute lung injury because trophic feeding can exacerbate protein limitations in the intensive care unit, 16 and such malnutrition might underlie important muscle loss, 17 persistent muscle weakness, and functional impairment in these patients. [18][19][20][21][22] Moreover, post hoc data analyses from a previous phase II randomised trial in mechanically ventilated patients in intensive care showed that they were more...

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“…Some evidence also suggests a lack of adverse consequences even with longer-term outcomes. A trophic/hypocaloric feeding trial of 525 patients, which instituted the most significant restrictions in enteral feeding (20% of caloric goal) for up to 6 days, found no differences in muscle strength, muscle mass, and 6-min walk test at 6 months or 1 year, although patients in the trophic/hypocaloric feeding group were more likely to be admitted to a rehabilitation facility during the first 12 months of follow-up [592]. The current evidence base would suggest that a trophic/hypocaloric or early full enteral feeding strategy is appropriate.…”

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“…Cognitive impairment, an outcome of vital importance to ARDS survivors and their caregivers (37), is common after ARDS (11,13,15,16). Emerging evidence suggests that mechanical ventilation per se may trigger neuronal apoptosis via vagal and dopaminergic pathways (36).…”

“…In survivors with cognitive impairment at 12 months, which constituted 55% of those examined, the average daily Pa O2 values (measured closest to 8:00 A.M.) were significantly lower compared with nonimpaired survivors (71 mm Hg [interquartile range, 67-80 mm Hg] vs. 86 mm Hg [interquartile range, 70-98 mm Hg]; P = 0.02) (13). In the most recent ARDSNet trial, long-term cognitive impairment was observed in 25% of survivors at 12 months (15,16). Compared PERSPECTIVES with prior trials (2, 3), the latest trial enrolled a greater proportion of subjects with mild ARDS (15,16).…”

“…ARDS survivors frequently experience long-term cognitive impairment, as well as physical impairment, psychiatric morbidity, and reduced health-related quality of life (7)(8)(9)(10)(11)(12)(13)(14)(15)(16). At present, no intensive care unit (ICU)-based intervention has been proven to reduce the risk of developing long-term cognitive impairment after ARDS.…”

“…To address the urgent need to identify strategies to preserve long-term health, investigators have advocated the measurement of short-and long-term outcomes in clinical trials (7,17). ARDS trials have incorporated long-term outcomes into their trial designs (13)(14)(15)(16), although current trials have not yet explicitly targeted long-term outcomes as their primary outcome.…”