Using L-citrulline for immunonutrition in ICU patients with sepsis

ICITRU : Randomized Trial of Immunonutrition With L-citrulline in Patients Hospitalized in Intensive Care for Sepsis or Septic Shock

This study is testing if giving L-citrulline to ICU patients with sepsis can improve their immune system and amino acid levels compared to a placebo.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rennes University Hospital (other)
• Drugs / interventions: chemotherapy, cyclophosphamide
• Locations: 5 sites (Rennes, Brittany Region and 4 other locations)
• Trial ID: NCT04513288 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of enteral administration of L-citrulline compared to a placebo in patients hospitalized in intensive care for sepsis or septic shock. The study aims to assess immunological parameters and amino acid levels over a 5-day period. It focuses on patients who have been admitted to the ICU within 4 days of initial infection and are on invasive mechanical ventilation. The trial will be conducted at Rennes University Hospital and Besançon University Hospital, with specific immunological assessments performed on a subset of patients in Rennes.

Who should consider this trial

Good fit: Ideal candidates include septic patients who have been admitted to intensive care within 4 days of infection and are on mechanical ventilation.

Not a fit: Patients with progressive SARS-CoV2 infection, pregnancy, morbid obesity, or existing immunosuppression may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve immune function and outcomes in critically ill patients suffering from sepsis.

How similar studies have performed: While immunonutrition has faced challenges in ICU settings, this specific approach using L-citrulline is novel and has not been extensively tested in similar trials.

Eligibility criteria

Inclusion Criteria:

* Septic patients in accordance with the definition of sepsis and septic shock published in 2016 (JAMA) and whose use is recommended by the European Society of Intensive Care Medicine;
* Initial aggression dated less than 4 days before admission to intensive care (selection of "community" patients). The onset of aggression will be defined by the onset of clinical signs of infection;
* Patients hospitalized for less than 48 hours before admission to intensive care (selection of patients without malnutrition and immunosuppression acquired in hospital) \*;
* Patients under invasive mechanical ventilation with a foreseeable ventilation duration\> 2 days \*\*;
* Exclusive enteral nutrition;
* Affiliation to a social security scheme;
* Consent signed by the patient, relative or legal representative or inclusion under emergency procedure

Non Inclusion Criteria:

* Progressive Sars-CoV2 infection
* Pregnancy in progress;
* Morbid obesity (BMI\> 40);
* State of immunosuppression defined by at least one of these criteria: continuous administration of steroids at any dose for more than one month before hospitalization, steroids at high doses (\> 0.5 mg / kg / day of methylprednisolone or equivalent), radiotherapy or chemotherapy in the previous year, proven humoral or cellular deficiency;
* Contraindication to enteral nutrition (SRLF 2016 recommendations: "Enteral nutrition should probably not be used upstream of a high flow digestive fistula in cases of intestinal obstruction, ischemia of the small intestine or digestive hemorrhage. active (Strong agreement) ");
* Participation in intervention research on a drug, or intervention research that could impact the immune system

Exclusion Criteria:

\- Institution of immunosuppressive therapy such as chemotherapy, cyclophosphamide, high dose corticosteroid therapy (\> 0.5 mg / kg / day ; hydrocortisone used in the management of septic shock is not considered an exclusion criterion).

Where this trial is running

Rennes, Brittany Region and 4 other locations

• Rennes University Hospital - Medical ICU — Rennes, Brittany Region, France (RECRUITING)
• Rennes University Hospital - Surgical ICU — Rennes, Brittany Region, France (TERMINATED)
• Besançon University Hospital — Besançon, France (RECRUITING)
• Le Mans Hospital — Le Mans, France (RECRUITING)
• Tours University Hospital — Tours, France (RECRUITING)

Study contacts

• Study coordinator: Mathieu Lesouhaitier, MD

Conditions: Sepsis, Septic Shock