Randomized clinical trial of gut-specific nutrients in critically ill surgical patients.

Abstract

Inadequate gut function is common and may adversely affect prognosis. However, it is difficult to measure and treatment options are limited. This study evaluated whether gut-specific nutrients (GSNs) could stimulate the return of gut function in critically ill patients, and assessed what effect, if any, this would have on patient outcomes. Consecutive critically ill patients intolerant to enteral feeding were randomized to receive a cocktail of GSNs or placebo. Administration was for 1 month and patients were followed for 3 months. The primary endpoint was the time to return of normal gut function. Twenty-five patients were randomized to each group. GSN administration was associated with a quicker return of normal gut function (median 164 versus 214 h; P = 0.016), attenuation of the acute-phase response and a lower incidence of sepsis (4 versus 13 patients, P = 0.015) compared with placebo. There were fewer deaths by 3 months in the GSN group but this did not achieve significance (2 versus 7 deaths; P = 0.138). GSNs expedite the return of gut function in the critically ill and improve outcomes. Inadequate gut function may be associated with poor prognosis similar to that of other single organ failures. ISRCTN61157513 (http://www.controlled-trials.com).