EARLY ENTERAL ADMINISTRATION OF A FORMULA (IMPACT((R))) SUPPLEMENTED WITH ARGININE, NUCLEOTIDES, AND FISH-OIL IN INTENSIVE-CARE UNIT PATIENTS - RESULTS OF A MULTICENTER, PROSPECTIVE, RANDOMIZED, CLINICAL-TRIAL

Objective: To determine if early enteral feeding, in an intensive care unit ICU) patient population, using a formula supplemented with argin ine, dietary nucleotides, and fish oil (Impact(R)), results in a short er hospital stay and a reduced frequency of infectious complications, when compared with feeding a common use enteral formula (Osmolite HN(R )). Design: A prospective, randomized, double-blind, multicenter trial . Setting: ICUs in eight different hospitals. Patients: Of 326 patient s enrolled in the study, 296 patients were eligible for analysis, They were admitted to the ICU after an event such as trauma, surgery, or s epsis, and met a risk assessment screen (Acute Physiology and Chronic Health Evaluation II [APACHE II] score of greater than or equal to 10, or a Therapeutic Intervention Scoring System score of greater than or equal to 20) and study eligibility requirements, Patients were strati fied by age (< 60 or greater than or equal to 60 yrs of age) and disea se (septic or systemic inflammatory response syndrome). Interventions: Patients were enrolled and full-strength tube feedings were initiated within 48 hrs of the study entry event, Enteral feedings were advance d to a target volume of 60 mL/hr by 96 hrs of the event, One hundred s ixty-eight patients were randomized to receive the experimental formul a, and 158 patients were randomized to receive the common use control formula. Measurements and Main Results: Both groups tolerated early en teral feeding well, and the frequency of tube feeding-related complica tions was low, There were no significant differences in nitrogen balan ce between groups on study days 4 and 7, Patients receiving the experi mental formula had a significant (p = .0001) increase in plasma argini ne and ornithine concentrations by study day 7. Plasma fatty acid prof iles demonstrated higher concentrations of linoleic acid (p < .01) in the patients receiving the common use formula and higher concentration s of eicosapentaenoic and docosahexaenoic acid (p < .01) in the patien ts receiving the experimental formula, The mortality rate was not diff erent between the groups and was significantly (p < .001) lower than p redicted by the admission severity scores in both feeding groups, In p atients who received at least 821 mL/day of the experimental formula, the hospital median length of stay was reduced by 8 days (p < .05), In patients stratified as septic, the median length of hospital stay was reduced by 10 days (p < .05), along with a major reduction in the fre quency of acquired infections (p < .01) in the patients who received t he experimental formula, In the septic subgroup fed at least 821 mL/da y, the median length of stay was reduced by 11.5 days, along with a ma jor reduction in acquired infections (both p < .05) in the patients wh o received the experimental formula. Conclusions: Early enteral feedin g of the experimental formula was safe and well tolerated in ICU patie nts. In patients who received the experimental formula, particularly i f they were septic on admission to; the study, a substantial reduction in hospital length of stay was observed, along with a significant red uction in the frequency of acquired infections.