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01-05-2003 | Brief Report

Early enteral immunonutrition in patients with severe sepsis

Results of an interim analysis of a randomized multicentre clinical trial

Authors: Guido Bertolini, Gaetano Iapichino, Danilo Radrizzani, Rebecca Facchini, Bruno Simini, Paola Bruzzone, Giancarlo Zanforlin, Gianni Tognoni

Published in: Intensive Care Medicine | Issue 5/2003

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.

Design

Randomised multicentre unblinded controlled clinical trial.

Setting

Thirty-three General Intensive Care Units in Italy.

Patients and participants

Among the 237 recruited patients, 39 had severe sepsis or septic shock; 21 of them received PN.

Interventions

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.

Measurements and 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.

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Title: Early enteral immunonutrition in patients with severe sepsis
Results of an interim analysis of a randomized multicentre clinical trial
Authors: Guido Bertolini
Gaetano Iapichino
Danilo Radrizzani
Rebecca Facchini
Bruno Simini
Paola Bruzzone
Giancarlo Zanforlin
Gianni Tognoni
Publication date: 01-05-2003
Publisher: Springer Berlin Heidelberg
Published in: Intensive Care Medicine / Issue 5/2003
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-003-1711-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Early enteral immunonutrition in patients with severe sepsis

Results of an interim analysis of a randomized multicentre clinical trial

Abstract

Objective

Design

Setting

Patients and participants

Interventions

Measurements and results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objective

Design

Setting

Patients and participants

Interventions

Measurements and results

Conclusions

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