title: Early goal-directed nutrition in ICU patients (EAT-ICU): protocol for a randomised trial.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  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).
  
  
  BACKGROUND
  Clinicaltrials.gov identifier no. NCT01372176.
authors: matilde.jo.allingstrup@regionh.dk.
authors: Matilde Jo
authors: MJ
authors: Allingstrup
authors: Jens
authors: J
authors: Kondrup
authors: Jørgen
authors: J
authors: Wiis
authors: Casper
authors: C
authors: Claudius
authors: Ulf Gøttrup
authors: UG
authors: Pedersen
authors: Rikke
authors: R
authors: Hein-Rasmussen
authors: Tom Hartvig
authors: TH
authors: Jensen
authors: Theis
authors: T
authors: Lange
authors: Anders
authors: A
authors: Perner
mesh_terms: D000368:Aged; D016638:Critical Illness / Q000628:therapy*; D005260:Female; D006040:Goals; D006760:Hospitalization / Q000639:trends; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D015596:Nutrition Assessment; D009752:Nutritional Status; D018529:Nutritional Support / Q000379:methods*; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome