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Immuno Nutrition by L-citrulline for Critically Ill Patients — Immunocitre  

Intubation Clinical Trial

Official title:
Immuno Nutrition by L-citrulline for Critically Ill Patients

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02864017
Study type Interventional
Source Rennes University Hospital
Contact
Status Completed
Phase N/A
Start date September 2016
Completion date April 2020
View Details
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