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 arginine, dietary nucleotides, and fish oil (Impact(R)), results in a shorter 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 patients enrolled in the study, 296 patients were eligible for analysis, They were admitted to the ICU after an event such as trauma, surgery, or sepsis, 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 stratified by age (< 60 or greater than or equal to 60 yrs of age) and disease (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 advanced to a target volume of 60 mL/hr by 96 hrs of the event, One hundred sixty-eight patients were randomized to receive the experimental formula, and 158 patients were randomized to receive the common use control formula. Measurements and Main Results: Both groups tolerated early enteral feeding well, and the frequency of tube feeding-related complications was low, There were no significant differences in nitrogen balance between groups on study days 4 and 7, Patients receiving the experimental formula had a significant (p = .0001) increase in plasma arginine and ornithine concentrations by study day 7. Plasma fatty acid profiles demonstrated higher concentrations of linoleic acid (p < .01) in the patients receiving the common use formula and higher concentrations of eicosapentaenoic and docosahexaenoic acid (p < .01) in the patients receiving the experimental formula, The mortality rate was not different between the groups and was significantly (p < .001) lower than predicted by the admission severity scores in both feeding groups, In patients 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 frequency of acquired infections (p < .01) in the patients who received the experimental formula, In the septic subgroup fed at least 821 mL/day, the median length of stay was reduced by 11.5 days, along with a major reduction in acquired infections (both p < .05) in the patients who received the experimental formula. Conclusions: Early enteral feeding of the experimental formula was safe and well tolerated in ICU patients. In patients who received the experimental formula, particularly if they were septic on admission to; the study, a substantial reduction in hospital length of stay was observed, along with a significant reduction in the frequency of acquired infections.