Immunocitre: Immuno Nutrition by L-citrulline for Critically Ill Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: L-Citrulline group Enteral nutrition 5-day L-citrulline treatment (10 grams/day) |
Procedure: Enteral nutrition
Dietary Supplement: L-Citrulline
|
| Placebo Comparator: Control group Enteral nutrition 5-day placebo treatment |
Procedure: Enteral nutrition
Dietary Supplement: Placebo
|
Outcome Measures
Primary Outcome Measures
- Organ failure score comparison D7 [At day 7]
Organ failure score (SOFA score) on day 7 in the L-citrulline group as compared to the placebo group
Secondary Outcome Measures
- Organ failure score comparison D3 [At day 3]
Organ failure score (SOFA score) on day 3 in the L-citrulline group as compared to the placebo group
- SOFA score evolution between randomisation and D7 [up to 7 days]
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;
- Expression of HLA-DR [At day 7]
Expression of HLA-DR in the L-citrulline group as compared to the placebo group
- Plasmatic concentration of IL6 [At day 7]
Comparison of the plasmatic concentration of interleukin-6 between the L-citrulline group and the placebo group
- HLA-DR [At day 7]
Comparison of the percentage of expression of monocytic HLA-DR between the L-citrulline group and the placebo group
- Plasmatic concentration of L-arginine [At day 7]
Comparison of the plasmatic concentration of L-arginine and its metabolites between the L-citrulline group and the placebo group
- Incidence of nosocomial infections [during the stay in the ICU, an average of 7 days]
Comparison between the L-citrulline group and the placebo group
- Length of stay [during the stay in hospital, up to 28 days]
Length of stay in ICU and hospital: Comparison between the L-citrulline group and the placebo group
- Mortality [during the stay in hospital, up to 28 days]
Mortality in intensive care and in hospital : Comparison between the L-citrulline group and the placebo group Duration of mechanical ventilation.
- Duration of mechanical ventilation [during the stay in ICU, an average of 7 days]
Duration of mechanical ventilation: Comparison between the L-citrulline group and the placebo group
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Angers | Angers | France | ||
| 2 | CHU Nantes | Nantes | France | ||
| 3 | Paris - HEGP | Paris | France | ||
| 4 | Rennes Hospital University | Rennes | France | 35033 |
Sponsors and Collaborators
- Rennes University Hospital
Investigators
- Principal Investigator: Jean-Marc TADIE, MD, CHU Rennes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 35RC14_9835
- 2015-A00961-48