Immuno Nutrition by L-citrulline for Critically Ill Patients (Immunocitre)

Rennes University Hospital

Status: Completed

Conditions: Pulmonary Ventilation; Intubation

Treatments: Dietary Supplement: Placebo; Procedure: Enteral nutrition; Dietary Supplement: L-Citrulline

Study type: Interventional

Funder types: Other

Identifiers

NCT02864017

2015-A00961-48 (Other Identifier)

35RC14_9835

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

L-Citrulline group

Experimental group

Description:

Enteral nutrition 5-day L-citrulline treatment (10 grams/day)

Treatment:

Procedure: Enteral nutrition

Dietary Supplement: L-Citrulline

Control group

Placebo Comparator group

Description:

Enteral nutrition 5-day placebo treatment

Treatment:

Procedure: Enteral nutrition

Dietary Supplement: Placebo