Enteral Nutrition Clinical Trial
Official title:
Safety and Efficacy of an Amino Acid Blend on Muscle and Gut Functionality in ICU Patients
Assessment of the Safety and efficacy of an amino acid blend on muscle and gut functionality in Intensive Care Unit (ICU) patients. Since this was a proof of concept, exploratory trial, we assessed different primary outcomes without hierarchy.
This monocentric trial was a parallel, randomized, double-blind, controlled study. Patients hospitalized in the ICU for sepsis or ARDS were enrolled. The treatment group (n=15) was administered the study product (amino acid blend) and the negative control group (=15) was administrated maltodextrin only. The mode of administration was nasogastric probe. The treatment period was 21 days. Subject were followed during stay in High care and intermediate care units up to 2 months or after hospital discharge with a follow up until 12 months. Recruitment stopped when 30 patients (15 in each group) reached V4. ;
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