title: Early enteral immunonutrition in patients with severe sepsis: results of an interim analysis of a randomized multicentre clinical trial.
abstract: OBJECTIVE
  To compare the mortality of critically ill patients given either enteral feeding with an immune-enhancing formula or parenteral nutrition (PN). We report the results of a planned interim analysis on patients with severe sepsis which was undertaken earlier than planned once a meta-analysis suggested excess mortality in patients with severe sepsis given enteral immunonutrition.
  
  
  METHODS
  Randomised multicentre unblinded controlled clinical trial.
  
  
  METHODS
  Thirty-three General Intensive Care Units in Italy.
  
  
  METHODS
  Among the 237 recruited patients, 39 had severe sepsis or septic shock; 21 of them received PN.
  
  
  METHODS
  Eligible patients received either total PN or enteral nutrition, the latter containing extra L-arginine, omega-3 fatty acids, vitamin E, beta carotene, zinc, and selenium.
  
  
  RESULTS
  The primary endpoint for the subgroup analysis on patients with severe sepsis was mortality on Intensive Care Unit (ICU). The ICU mortality of patients with severe sepsis given enteral nutrition (EN) was higher than for those given PN (44.4% vs 14.3%; p=0.039). More patients given EN than patients given PN still had severe sepsis when they died (38.9% vs 9.5%, p=0.055). Recruitment of patients with severe sepsis was subsequently stopped.
  
  
  CONCLUSIONS
  Our results show that enteral immunonutrition, compared to PN, may be associated with excess mortality in patients with severe sepsis.
authors.affiliation: GiViTI Coordinating Center, Istituto di Ricerche Farmacologiche Mario Negri, Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò, Ranica, Bergamo, Italy. bertolini@marionegri.it
authors.forename: Guido
authors.initials: G
authors.lastname: Bertolini
authors.forename: Gaetano
authors.initials: G
authors.lastname: Iapichino
authors.forename: Danilo
authors.initials: D
authors.lastname: Radrizzani
authors.forename: Rebecca
authors.initials: R
authors.lastname: Facchini
authors.forename: Bruno
authors.initials: B
authors.lastname: Simini
authors.forename: Paola
authors.initials: P
authors.lastname: Bruzzone
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Zanforlin
authors.forename: Gianni
authors.initials: G
authors.lastname: Tognoni
mesh_terms: D018806:APACHE; D002149:Energy Intake; D004750:Enteral Nutrition; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D007558:Italy; D008297:Male; D008875:Middle Aged; D010288:Parenteral Nutrition; D018805:Sepsis / Q000145:classification / Q000401:mortality / Q000628:therapy