Clinical trial NCT02864017: Immuno Nutrition by L-citrulline for Critically Ill Patients
Official title: Immuno Nutrition by L-citrulline for Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Pulmonary Ventilation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Organ failure score comparison D7
timeFrame: At day 7
Secondary outcomes:
measure: Organ failure score comparison D3
timeFrame: At day 3
measure: SOFA score evolution between randomisation and D7
timeFrame: up to 7 days
measure: Expression of HLA-DR
timeFrame: At day 7
measure: Plasmatic concentration of IL6
timeFrame: At day 7
measure: HLA-DR
timeFrame: At day 7
measure: Plasmatic concentration of L-arginine
timeFrame: At day 7
measure: Incidence of nosocomial infections
timeFrame: during the stay in the ICU, an average of 7 days
measure: Length of stay
timeFrame: during the stay in hospital, up to 28 days
measure: Mortality
timeFrame: during the stay in hospital, up to 28 days
measure: Duration of mechanical ventilation
timeFrame: during the stay in ICU, an average of 7 days
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Paris - HEGP
city: Rennes
country: France
facility: Rennes Hospital University
Study officials:
affiliation: CHU Rennes
name: Jean-Marc TADIE, MD
role: PRINCIPAL_INVESTIGATOR
References: