A Randomized Controlled Study to Evaluate the Effect of an Enteral Formulation

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A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient – the SPIRIT trial. In this pilot study, we found a high incidence of diarrhea, which was not attenuated by Peptamen AF. Patients with diarrhea stayed longer in the ICU. Median age was 63.3 (interquartile range (IQR) 51.0–73.2) years and Simplified Acute Physiology Score (SAPS) II was 61.0 (IQR 47.8–74). Time to reach caloric goal (intervention: 2.2 (0.8–3.7) days (median, IQR); control: 2.0 (1.3–2.7) days; p = 0.16), length of time on study nutrition (intervention: 5.0 (3.6–6.4) days; control: 7.0 (5.3–8.7) days; p = 0.26), and calorie intake (intervention: 18.0 (12.5–20.9) kcal/kg/day; control 19.7 (17.3–23.1) kcal/kg/day; p = 0.08) did not differ between groups.

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