Immuno Nutrition by L-citrulline for Critically Ill Patients

Rennes University Hospital120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

120

Conditions

Intubation Pulmonary Ventilation

Interventions

Enteral nutritionPROCEDURE

L-CitrullineDIETARY_SUPPLEMENT

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age \> 18 years * medical patient (absence of recent surgery or trauma) * initial aggression \< 5 days * mechanically ventilated with expected duration of mechanical ventilation \> 2 days * exclusive enteral nutrition * absence of previous immunosuppression Exclusion Criteria: * severe sepsis * septic shock * obesity defined as BMI above 40 * pregnancy

Locations (4)

CHU Angers

Angers, France

CHU Nantes

Nantes, France

Paris - HEGP

Paris, France

Rennes Hospital University

Rennes, France

Outcomes

Primary Outcomes

Organ failure score comparison D7

Organ failure score (SOFA score) on day 7 in the L-citrulline group as compared to the placebo group

Time frame: At day 7

Secondary Outcomes

Organ failure score comparison D3

Organ failure score (SOFA score) on day 3 in the L-citrulline group as compared to the placebo group

Time frame: At day 3

SOFA score evolution between randomisation and D7

Binary criterion of success or failure : \- Success is defined by: an improved SOFA score of at least 2 points from randomization to Day 7 or an improvement in the general condition yielding the release of the unit; \- Failure is defined by an improved SOFA score but less than 2 points, no improvement or worsening of the SOFA score from randomization to Day 7 or the patient's death before J7;

Time frame: up to 7 days

Expression of HLA-DR

Expression of HLA-DR in the L-citrulline group as compared to the placebo group

Time frame: At day 7

Plasmatic concentration of IL6

Comparison of the plasmatic concentration of interleukin-6 between the L-citrulline group and the placebo group

Time frame: At day 7

HLA-DR

Comparison of the percentage of expression of monocytic HLA-DR between the L-citrulline group and the placebo group

Time frame: At day 7

Plasmatic concentration of L-arginine

Comparison of the plasmatic concentration of L-arginine and its metabolites between the L-citrulline group and the placebo group

Data from ClinicalTrials.gov

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