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

Dale M Needham, Victor D Dinglas, O Joseph Bienvenu, Elizabeth Colantuoni, Amy W Wozniak, Todd W Rice, Ramona O Hopkins, NIH NHLBI ARDS Network, S Gundel, C Hough, M Neff, K Sims, A Ungar, T Watkins, J Steingrub, M Tidswell, E Braden, L DeSouza, J Germain, C Kardos, D Kelley, L Kozikowski, K Guntupalli, V Bandi, C Pope, C Ross, R Brower, H Fessler, D Hager, D Needham, K Oakjones, J Sevransky, A Workneh, C Shanholtz, D Herr, H Howes, G Netzer, P Rock, A Sampaio, J Titus, P Sloane, T Beck, D Highfield, S King, B Lee, N Bolouri, H P Wiedemann, R W Ashton, D A Culver, T Frederick, J A Guzman, J J Komara Jr, A J Reddy, R Hejal, M Andrews, D Haney, A F Connors, S Lasalvia, J D Thornton, E L Warren, M Moss, E L Burnham, L Gray, J Maloney, I Douglas, K Overdier, K Thompson, R Wolken, S Frankel, J McKeehan, M L Warner, T Bost, C Higgins, K Hodgin, N MacIntyre, L Brown, M Gentile, J Govert, N Knudsen, S Carson, L Chang, S Choudhury, W Hall, J Lanier, A P Wheeler, G R Bernard, M Hays, S Mogan, T W Rice, R D Hite, K Bender, A Harvey, P E Morris, Mary Ragusky, P Wright, S Groce, J McLean, A Overton, J Truwit, K Enfield, M Marshall, A Morris, S Barney, S Brown, J Fergeson, H Gallo, T Graydon, C Grissom, E Hirshberg, A Jephson, N Kumar, R Miller, D Murphy, J Orme, L Struck, F Thomas, D Ward, L Weaver, P Bailey, W Beninati, L Bezdijan, T Clemmer, S Rimkus, R Tanaka, C Lawton, D Hanselman, K Sundar, W Alward, C Bishop, D Eckley, T Hill, B Jensen, K Ludwig, D Nielsen, M Pearce, M A Matthay, C Calfee, B Daniel, M Eisner, O Garcia, K Kordesch, K Liu, N Shum, H Zhou, M W Peterson, J Blaauw, K Van Gundy, T Albertson, B Morrissey, E Vlastelin, A Antoine, D Charbonnet, J Hunt, P Lauto, A Marr, G Meyaski, R Tejedor, S Brierre, J Byrne, T Jagneaux, C LeBlanc, K Moreau, C Thomas, S Jain, D Taylor, L Seoane, C Hebert, J Thompson, F Simeone, J Fearon, D Schoenfeld, M Guha, E Hammond, N Lavery, P Lazar, R Morse, N Ringwood, E Smoot, B T Thompson, R Wilson, A Harabin, S Bredow, M Waclawiw, R G Spragg, A Slutsky, M Levy, B Markovitz, E Petkova, C Weijer, J Sznajder, M Begg, E Israel, J Lewis, S McClave, P Parsons, L Hudson, S Ouellette, P Mendez-Tellez, A Austin, A Stow, B deBoisblanc, C Romaine, C Oldmixon, Dale M Needham, Victor D Dinglas, O Joseph Bienvenu, Elizabeth Colantuoni, Amy W Wozniak, Todd W Rice, Ramona O Hopkins, NIH NHLBI ARDS Network, S Gundel, C Hough, M Neff, K Sims, A Ungar, T Watkins, J Steingrub, M Tidswell, E Braden, L DeSouza, J Germain, C Kardos, D Kelley, L Kozikowski, K Guntupalli, V Bandi, C Pope, C Ross, R Brower, H Fessler, D Hager, D Needham, K Oakjones, J Sevransky, A Workneh, C Shanholtz, D Herr, H Howes, G Netzer, P Rock, A Sampaio, J Titus, P Sloane, T Beck, D Highfield, S King, B Lee, N Bolouri, H P Wiedemann, R W Ashton, D A Culver, T Frederick, J A Guzman, J J Komara Jr, A J Reddy, R Hejal, M Andrews, D Haney, A F Connors, S Lasalvia, J D Thornton, E L Warren, M Moss, E L Burnham, L Gray, J Maloney, I Douglas, K Overdier, K Thompson, R Wolken, S Frankel, J McKeehan, M L Warner, T Bost, C Higgins, K Hodgin, N MacIntyre, L Brown, M Gentile, J Govert, N Knudsen, S Carson, L Chang, S Choudhury, W Hall, J Lanier, A P Wheeler, G R Bernard, M Hays, S Mogan, T W Rice, R D Hite, K Bender, A Harvey, P E Morris, Mary Ragusky, P Wright, S Groce, J McLean, A Overton, J Truwit, K Enfield, M Marshall, A Morris, S Barney, S Brown, J Fergeson, H Gallo, T Graydon, C Grissom, E Hirshberg, A Jephson, N Kumar, R Miller, D Murphy, J Orme, L Struck, F Thomas, D Ward, L Weaver, P Bailey, W Beninati, L Bezdijan, T Clemmer, S Rimkus, R Tanaka, C Lawton, D Hanselman, K Sundar, W Alward, C Bishop, D Eckley, T Hill, B Jensen, K Ludwig, D Nielsen, M Pearce, M A Matthay, C Calfee, B Daniel, M Eisner, O Garcia, K Kordesch, K Liu, N Shum, H Zhou, M W Peterson, J Blaauw, K Van Gundy, T Albertson, B Morrissey, E Vlastelin, A Antoine, D Charbonnet, J Hunt, P Lauto, A Marr, G Meyaski, R Tejedor, S Brierre, J Byrne, T Jagneaux, C LeBlanc, K Moreau, C Thomas, S Jain, D Taylor, L Seoane, C Hebert, J Thompson, F Simeone, J Fearon, D Schoenfeld, M Guha, E Hammond, N Lavery, P Lazar, R Morse, N Ringwood, E Smoot, B T Thompson, R Wilson, A Harabin, S Bredow, M Waclawiw, R G Spragg, A Slutsky, M Levy, B Markovitz, E Petkova, C Weijer, J Sznajder, M Begg, E Israel, J Lewis, S McClave, P Parsons, L Hudson, S Ouellette, P Mendez-Tellez, A Austin, A Stow, B deBoisblanc, C Romaine, C Oldmixon

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.

Trial registration: ClinicalTrials.gov NCT00719446.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4790760/bin/need010202.f1_default.jpg
Fig 1 Survival until 12 months after randomisation. Curves at any time point represent proportion of patients surviving in study at that time. Two consenting patients were censored at date of six month assessment because of loss to follow-up thereafter. Patients known to be alive but who missed their 12 month follow-up were administratively censored at expected date of their 12 month assessment
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4790760/bin/need010202.f2_default.jpg
Fig 2 Enrolment and follow-up of patients with acute lung injury according to initial feeding regimen. *Three of 44 hospitals in EDEN trial did not participate in follow-up study, reducing original sample size from 1000 to 951; †eight known to be alive at 12 months, two others were censored for survival analysis; ‡known to be alive at 12 months
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4790760/bin/need010202.f3_default.jpg
Fig 3 Effect size (treatment effect) of treatment intervention on primary outcome (SF-36 physical function domain adjusted for age and sex) and all secondary outcomes at 12 months. Effect size calculated as treatment effect (difference in means or proportions, see table 3) divided by pooled SD from trophic and full feeding groups. FACIT=functional assessment of chronic illness therapy, IES-R=impact of events scale-revised

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