Intubation Clinical Trial
Official title:
Immuno Nutrition by L-citrulline for Critically Ill Patients
The main objective of this study is to demonstrate that the only administration of L-citrulline, can improve immune functions in critically ill patients at high risk of nosocomial infection.
This is a multicentric therapeutic trial, randomized and double blind: standard enteral
nutrition plus L-citrulline (5 grams/12 Hours for 5 days from the admission in Intensive Care
Unit (ICU)) versus standard enteral nutrition plus placebo.
Methods-Patients: Non-surgical patients admitted in medical intensive care unit, under
mechanical ventilation for an expected duration > 2 days, without severe sepsis or septic
shock, will be enrolled. Symptoms leading for ICU admission ongoing for five days maximum. On
admission (before treatment), the severity will be evaluated with the Sepsis-related Organ
Failure Assessment (SOFA) score together with an assessment of plasmatic arginine, cytokines
(InterLeukin-6 (IL6) ), and expression of Human Leukocyte Antigen - antigen D Related
(HLA-DR) by monocytes. The same evaluation will be repeated on day 3 (during treatment) and
on day 7 (after treatment).
The enrolment of 100 patients is statistically enough to demonstrate a decreased SOFA scores
in the L-citrulline group as compared to the placebo group on day 7.
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