A prospective, randomized, double-blind, controlled clinical trial of enteral immunonutrition in the critically ill. Guy's Hospital Intensive Care Group.

Abstract

OBJECTIVE:

To assess the effects of enteral immunonutrition (IMN) on hospital mortality and length of stay in a heterogeneous group of critically ill patients.

DESIGN:

Prospective, randomized, double-blind, controlled clinical trial with an a priori subgroup analysis according to the volume of feed delivered in the first 72 hrs of intensive care unit (ICU) admission.

SETTING:

A 13-bed adult general ICU in a London teaching hospital.

PATIENTS:

A total of 398 patients were enrolled and data from 390 patients (IMN = 193, control = 197) were used for an intention-to-treat analysis. There were 369 patients (IMN = 184, control = 185) who actually received some enteral nutrition, of whom 101 patients (IMN = 50, control = 51) received >2.5 L within 72 hrs of ICU admission. This latter group was defined as the successful "early enteral nutrition" group.

INTERVENTIONS:

Within 48 hrs of ICU admission, patients were randomized to receive either the IMN Impact (Novartis Nutrition), an enteral feed supplemented with arginine, purine nucleotides and omega-3 fatty acids, or an isocaloric, isonitrogenous control enteral feed.

MEASUREMENTS AND RESULTS:

There was no significant difference in hospital mortality rate between the two groups on an intention-to-treat analysis (Impact group 48%, control group 44%) nor in any other predefined subgroup analysis. However, patients randomized to receive the IMN had higher Acute Physiology and Chronic Health Evaluation II scores (20.1 +/- 7.1 vs. 18.7 +/- 7.1 [p = .07] intention-to-treat [n = 390]; 20.1 +/- 7.2 vs. 18.5 +/- 7.1 [p = .04] received feed [n = 369]). Of the 101 patients achieving early enteral nutrition, those patients fed with the IMN had a significant reduction in their requirement for mechanical ventilation compared with controls (median duration of ventilation 6.0 and 10.5 days, respectively, p = .007) with an associated reduction in the length of hospital stay (medians 15.5 and 20 days, respectively, p = .03).

CONCLUSION:

While the administration of enteral IMN to a general, critically ill population did not affect mortality, those patients in whom it was possible to achieve early enteral nutrition with Impact had a significant reduction in the morbidity of their critical illness.

• Authors: S Atkinson, E Sieffert, D Bihari
• Journal: Critical care medicine (Crit Care Med) Vol. 26 Issue 7 Pg. 1164-72 (Jul 1998) ISSN: 0090-3493 [Print] United States
• PMID: 9671364 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• APACHE
• Adult
• Aged
• Aged, 80 and over
• Clinical Protocols
• Critical Care (methods)
• Diagnosis-Related Groups
• Double-Blind Method
• Enteral Nutrition
• Female
• Food, Formulated
• Hospital Mortality
• Humans
• Immunocompetence
• Intensive Care Units (standards, statistics & numerical data)
• Length of Stay (statistics & numerical data)
• London
• Male
• Middle Aged
• Prospective Studies
• Respiration, Artificial (statistics & numerical data)
• Severity of Illness Index
• Survival Analysis
• Time Factors
• Treatment Outcome