Immuno Nutrition by L-citrulline for Critically Ill Patients

Intubation Clinical Trial

— Immunocitre  

Official title:

Immuno Nutrition by L-citrulline for Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864017
• Other study ID #: 35RC14_9835
• Secondary ID: 2015-A00961-48
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: April 2020

Study information

• Verified date: June 2020
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Intubation
• Pulmonary Ventilation

Intervention

Procedure:
• Enteral nutrition

Dietary Supplement:
• L-Citrulline

• Placebo

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Nantes	Nantes
France	Paris - HEGP	Paris
France	Rennes Hospital University	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Organ failure score comparison D7	Organ failure score (SOFA score) on day 7 in the L-citrulline group as compared to the placebo group	At day 7
Secondary	Organ failure score comparison D3	Organ failure score (SOFA score) on day 3 in the L-citrulline group as compared to the placebo group	At day 3
Secondary	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;	up to 7 days
Secondary	Expression of HLA-DR	Expression of HLA-DR in the L-citrulline group as compared to the placebo group	At day 7
Secondary	Plasmatic concentration of IL6	Comparison of the plasmatic concentration of interleukin-6 between the L-citrulline group and the placebo group	At day 7
Secondary	HLA-DR	Comparison of the percentage of expression of monocytic HLA-DR between the L-citrulline group and the placebo group	At day 7
Secondary	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	At day 7
Secondary	Incidence of nosocomial infections	Comparison between the L-citrulline group and the placebo group	during the stay in the ICU, an average of 7 days
Secondary	Length of stay	Length of stay in ICU and hospital: Comparison between the L-citrulline group and the placebo group	during the stay in hospital, up to 28 days
Secondary	Mortality	Mortality in intensive care and in hospital : Comparison between the L-citrulline group and the placebo group; Duration of mechanical ventilation.	during the stay in hospital, up to 28 days
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation: Comparison between the L-citrulline group and the placebo group	during the stay in ICU, an average of 7 days