Early goal-directed nutrition in ICU patients (EAT-ICU): protocol for a randomised trial.

INTRODUCTION: Extensive weight loss has been docu-mented in intensive care unit (ICU) survivors, primarily as the result of muscle loss, leading to impaired physical function and reduced quality of life. The aim of the EAT-ICU trial is to test the effect of early goal-directed protein-energy nutrition based on measured requirements on short-term clinical outcomes and long-term physical quality of life in ICU patients.

METHODS: The EAT-ICU trial is a single-centre, randomised, parallel-group trial with concealed allocation and blinded outcome assessment. A total of 200 consecutive, acutely admitted, mechanically ventilated intensive care patients will be randomised 1:1 to early goal-directed nutrition versus standard of care to show a potential 15% relative risk reduction in the primary outcome measure (physical function) at six months (two-sided significance level α = 0.05; power β = 80%). Secondary outcomes include energy- and protein balances, metabolic control, new organ failure, use of life support, nosocomial infections, ICU- and hospital length of stay, mortality and cost analyses.

CONCLUSION: The optimal nutrition strategy for ICU patients remains unsettled. The EAT-ICU trial will provide important data on the effects of early goal-directed protein-energy nutrition based on measured requirements in these patients.

FUNDING: The EAT-ICU trial is funded by Copenhagen University Hospital, Rigshospitalet and Fresenius Kabi A/S and supported by The European Society for Clinical Nutrition and Metabolism (ESPEN).

TRIAL REGISTRATION: Clinicaltrials.gov identifier no. NCT01372176.