Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2003 May;29(5):834-40.
doi: 10.1007/s00134-003-1711-5. Epub 2003 Apr 9.

Early enteral immunonutrition in patients with severe sepsis: results of an interim analysis of a randomized multicentre clinical trial

Guido Bertolini  1 , Gaetano Iapichino, Danilo Radrizzani, Rebecca Facchini, Bruno Simini, Paola Bruzzone, Giancarlo Zanforlin, Gianni Tognoni
Affiliations
Clinical Trial

Early enteral immunonutrition in patients with severe sepsis: results of an interim analysis of a randomized multicentre clinical trial

Guido Bertolini et al. Intensive Care Med. 2003 May.

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.

PubMed Disclaimer

Comment in

References

    1. JPEN J Parenter Enteral Nutr. 1995 Nov-Dec;19(6):453-60 - PubMed
    1. Intensive Care Med. 1997 Jul;23(7):760-5 - PubMed
    1. Intensive Care Med. 2001 Jan;27(1):131-6 - PubMed
    1. JPEN J Parenter Enteral Nutr. 2001 Mar-Apr;25(2 Suppl):S36-42; discussion S42-3 - PubMed
    1. Control Clin Trials. 1989 Dec;10(4 Suppl):209S-221S - PubMed