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Early goal-directed nutrition versus standard of care in adult intensive care patients: the single-centre, randomised, outcome assessor-blinded EAT-ICU trial

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Abstract

Purpose

We assessed the effects of early goal-directed nutrition (EGDN) vs. standard nutritional care in adult intensive care unit (ICU) patients.

Methods

We randomised acutely admitted, mechanically ventilated ICU patients expected to stay longer than 3 days in the ICU. In the EGDN group we estimated nutritional requirements by indirect calorimetry and 24-h urinary urea aiming at covering 100% of requirements from the first full trial day using enteral and parenteral nutrition. In the standard of care group we aimed at providing 25 kcal/kg/day by enteral nutrition. If this was not met by day 7, patients were supplemented with parenteral nutrition. The primary outcome was physical component summary (PCS) score of SF-36 at 6 months. We performed multiple imputation for data of the non-responders.

Results

We randomised 203 patients and included 199 in the intention-to-treat analyses; baseline variables were reasonably balanced between the two groups. The EGDN group had less negative energy (p < 0.001) and protein (p < 0.001) balances in the ICU as compared to the standard of care group. The PCS score at 6 months did not differ between the two groups (mean difference 0.0, 95% CI −5.9 to 5.8, p = 0.99); neither did mortality, rates of organ failures, serious adverse reactions or infections in the ICU, length of ICU or hospital stay, or days alive without life support at 90 days.

Conclusions

EGDN did not appear to affect physical quality of life at 6 months or other important outcomes as compared to standard nutrition care in acutely admitted, mechanically ventilated, adult ICU patients.

Clinicaltrials.gov identifier no. NCT01372176.

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Acknowledgements

We warmly thank past and present employees at the Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet for good spirits and positive collaboration during the trial period. The research nurses, Jette Degn and Vibeke Knudsen in particular, have made a huge difference during this project. We also thank Sofie L. Rygaard, Maj-Brit N. Kjær, Peter B. Hjortrup and Rasmus B. Müller for their help, and Gordon S. Doig for his invaluable input during the statistical analyses.

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Authors and Affiliations

  1. Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

    Matilde Jo Allingstrup, Jørgen Wiis, Casper Claudius, Ulf Gøttrup Pedersen, Rikke Hein-Rasmussen, Mads Rye Bjerregaard, Morten Steensen, Tom Hartvig Jensen, Martin Bruun Madsen, Morten Hylander Møller & Anders Perner

  2. Department of Clinical Nutrition, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

    Jens Kondrup

  3. Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark

    Theis Lange

  4. Centre for Statistical Science, Peking University, Beijing, China

    Theis Lange

Authors
  1. Matilde Jo Allingstrup
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  2. Jens Kondrup
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  12. Morten Hylander Møller
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Contributions

MJA, JW, JK and AP designed the study. MJA, JW, CC, UGP, RHR, MS, THJ, MRB and MHM collected the data. MJA and AP analysed the data and TL and MBM assisted with statistical analyses. MJA, AP and JK planned the article and MJA produced a detailed outline of the manuscript. All authors reviewed the article critically, contributed significantly and approved the final manuscript.

Corresponding author

Correspondence to Anders Perner.

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Conflicts of interest

The trial was funded by Rigshospitalet and supported by Fresenius Kabi, The European Society for Clinical Nutrition and Metabolism (ESPEN), COSMED and Medinor/MedGraphics. The funders had no roles in designing or executing the trial, in analyses of the data, in writing of the manuscript or in the decision to publish. The Department of Intensive Care, Rigshospitalet receives support for research from CSL Behring and Ferring Pharmaceuticals.

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Allingstrup, M.J., Kondrup, J., Wiis, J. et al. Early goal-directed nutrition versus standard of care in adult intensive care patients: the single-centre, randomised, outcome assessor-blinded EAT-ICU trial. Intensive Care Med 43, 1637–1647 (2017). https://doi.org/10.1007/s00134-017-4880-3

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