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

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

BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f1532 (Published 19 March 2013) Cite this as: BMJ 2013;346:f1532
  1. Dale M Needham, associate professor123,
  2. Victor D Dinglas, research program supervisor12,
  3. O Joseph Bienvenu, associate professor145,
  4. Elizabeth Colantuoni, assistant scientist16,
  5. Amy W Wozniak, research associate16,
  6. Todd W Rice, assistant professor7,
  7. Ramona O Hopkins, professor89
  8. for the NIH NHLBI ARDS Network
  1. 1Outcomes After Critical Illness and Surgery Group, Johns Hopkins University, Baltimore, MD 21205, USA
  2. 2Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD 21205, USA
  3. 3Department of Physical Medicine and Rehabilitation, School of Medicine, Johns Hopkins University, Baltimore, MD 21205, USA
  4. 4Department of Psychiatry and Behavioral Sciences, School of Medicine, Johns Hopkins University, Baltimore, MD 21205, USA
  5. 5Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21205, USA
  6. 6Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21205, USA
  7. 7Division of Allergy, Pulmonary, and Critical Care Medicine, School of Medicine, Vanderbilt University, Nashville, TN 37232, USA
  8. 8Department of Medicine, Pulmonary and Critical Care Division, Intermountain Medical Center, Murray, UT 84107, USA
  9. 9Psychology Department and Neuroscience Center, Brigham Young University, Provo, UT 84602, USA
  1. Correspondence to: D Needham, Pulmonary and Critical Care Medicine, Johns Hopkins University, 1830 E Monument Street, Baltimore, MD 21205, USA dale.needham{at}jhmi.edu
  • Accepted 19 February 2013

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

Footnotes

  • We thank all patients and their proxies who participated in the study. We thank Melissa McCullough, Mardee Merrill, Elizabeth Vayda, Jonathan Gellar, Laura Methvin, Gita Byraiah, Shirani Rajan, Elizabeth Fuller, and Cassie Wicken who assisted with data collection; and William Flickinger, and Christopher Mayhew who assisted with data management.

  • The National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network: University of Washington, Harborview (*L Hudson, S Gundel, C Hough, M Neff, K Sims, A Ungar, T Watkins); Baystate Medical Center (*J Steingrub, M Tidswell, E Braden, L DeSouza, J Germain, C Kardos, D Kelley, L Kozikowski, S Ouellette); Baylor College of Medicine (K Guntupalli, V Bandi, C Pope, C Ross); Johns Hopkins University (*R Brower, H Fessler, D Hager, P Mendez-Tellez, D Needham, K Oakjones); Johns Hopkins Bayview Medical Center (J Sevransky, A Workneh); University of Maryland (C Shanholtz, D Herr, H Howes, G Netzer, P Rock, A Sampaio, J Titus); Union Memorial Hospital (P Sloane, T Beck, D Highfield, S King); Washington Hospital Center (B Lee, N Bolouri); Cleveland Clinic Foundation (*H P Wiedemann, R W Ashton, D A Culver, T Frederick, J A Guzman, J J Komara Jr, A J Reddy); University Hospitals of Cleveland (R Hejal, M Andrews, D Haney); MetroHealth Medical Center (A F Connors, S Lasalvia, J D Thornton, E L Warren); University of Colorado Hospital, Aurora (*M Moss, E L Burnham, L Gray, J Maloney, M Mealer); Denver Health Medical Center (I Douglas, K Overdier, K Thompson, R Wolken); Rose Medical Center (S Frankel, J McKeehan); Swedish Medical Center (M L Warner); Saint Anthony’s Hospital (T Bost, C Higgins, K Hodgin); Duke University (*N MacIntyre, L Brown, C Cox, M Gentile, J Govert, N Knudsen); University of North Carolina (S Carson, L Chang, S Choudhury, W Hall, J Lanier); Vanderbilt University (*A P Wheeler, G R Bernard, M Hays, S Mogan, T W Rice); Wake Forest University (*R D Hite, K Bender, A Harvey, P E Morris, Mary Ragusky); Moses Cone Memorial Hospital (P Wright, S Groce, J McLean, A Overton); University of Virginia (J Truwit, K Enfield, M Marshall); LDS Hospital and Intermountain Medical Center (*A Morris, A Austin, S Barney, S Brown, J Fergeson, H Gallo, T Graydon, C Grissom, E Hirshberg, A Jephson, N Kumar, R Miller, D Murphy, J Orme, A Stow, L Struck, F Thomas, D Ward, L Weaver); LDS Hospital (P Bailey, W Beninati, L Bezdijan, T Clemmer, S Rimkus, R Tanaka); McKay Dee Hospital (C Lawton, D Hanselman); Utah Valley Regional Medical Center (K Sundar, W Alward, C Bishop, D Eckley, T Hill, B Jensen, K Ludwig, D Nielsen, M Pearce); University of California, San Francisco (*M A Matthay, C Calfee, B Daniel, M Eisner, O Garcia, K Kordesch, K Liu, N Shum, H Zhou); University of California, San Francisco, Fresno (M W Peterson, J Blaauw, K Van Gundy); University of California, Davis (T Albertson, B Morrissey, E Vlastelin); Louisiana State University Health Sciences Center-New Orleans (*B deBoisblanc, A Antoine, D Charbonnet, J Hunt, P Lauto, A Marr, G Meyaski, C Romaine, R Tejedor); Earl K Long Medical Center, Baton Rouge General Medical Center Mid-City and Baton Rouge General Medical Center Bluebonnet (S Brierre, J Byrne, T Jagneaux, C LeBlanc, K Moreau, C Thomas); Ochsner Clinic Foundation (S Jain, D Taylor, L Seoane); Our Lady of the Lake Medical Center (C Hebert, J Thompson); Tulane Medical Center (F Simeone, J Fearon) Clinical Coordinating Center: Massachusetts General Hospital and Harvard Medical School (*D Schoenfeld, M Guha, E Hammond, N Lavery, P Lazar, R Morse, C Oldmixon, N Ringwood, E Smoot, B T Thompson, R Wilson) National Heart, Lung and Blood Institute: A Harabin, S Bredow, M Waclawiw, G Weinmann Data and Safety Monitoring Board: R G Spragg (chair), A Slutsky, M Levy, B Markovitz, E Petkova, C Weijer Protocol Review Committee: J Sznajder (chair), M Begg, E Israel, J Lewis, S McClave, P Parsons. *Principal investigator.

  • Contributors: DMN and ROH contributed to conception and design of the manuscript. DMN, VDD, OJB, EC, AWW, TWR, and ROH contributed to analysis and interpretation of data. DMN drafted the article and all other authors critically revised it for important intellectual content. All authors gave final approval of the manuscript version to be published. DMN and EC are guarantors.

  • Funding: National Heart, Lung and Blood Institute funded this follow-up study (N01HR56170, R01HL091760 and 3R01HL091760-02S1) and the EDEN trial (contracts HHSN268200536165C to HHSN268200536176C and HHSN268200536179C). All researchers are independent of the funding bodies. The funding bodies had no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the manuscript for publication.

  • 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.

  • Ethical approval: The study was approved by the institutional review boards at each participating hospital, the two centres performing outcome assessments, and the EDEN data and safety monitoring board; and informed consent was given by all patients or their proxy.

  • Data sharing: No additional data available

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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