• Guido Bertolini, Gaetano Iapichino, Danilo Radrizzani, Rebecca Facchini, Bruno Simini, Paola Bruzzone, Giancarlo Zanforlin, and Gianni Tognoni.
• 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
• Intensive Care Med. 2003 May 1;29(5):834-40.

ObjectiveTo 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.DesignRandomised multicentre unblinded controlled clinical trial.SettingThirty-three General Intensive Care Units in Italy.Patients And ParticipantsAmong the 237 recruited patients, 39 had severe sepsis or septic shock; 21 of them received PN.InterventionsEligible 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.Measurements And ResultsThe 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.ConclusionsOur results show that enteral immunonutrition, compared to PN, may be associated with excess mortality in patients with severe sepsis.

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