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Study identifier: NCT04513288 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Sepsis · Septic Shock  ·  Sponsor: Rennes University Hospital

PhaseNA
Planned participants130
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Immunonutrition in intensive care has not yet demonstrated a beneficial effect on organ failure, the acquisition of nosocomial infections, or mortality. It did not correct for acquired immunosuppression in intensive care patients. Despite numerous methodological problems (use of several pharmaconutrients, very heterogeneous set of patients) and the absence of clinical data, deleterious effects have been attributed to immunonutrition in intensive care, in particular in septic patients and patients in intensive care . Arginine (ARG) is a semi-essential amino acid involved in many immunological mechanisms. It is synthesized in sufficient quantity under normal conditions but quickly becomes insufficient under catabolic conditions such as in severe sepsis. Arginine is not only the precursor of nitrogen monoxide (NO) but also an essential substrate for numerous enzymatic reactions which participate in the maintenance of immune homeostasis, in particular T lymphocyte function. Depletion of the cellular medium in arginine will induce an abnormality in the metabolism of immune cells responsible for a dysfunction of these cells (lymphopenia linked to early apoptosis) and thus expose patients to organ failure and nosocomial infections. It has been found that hypoargininemia in intensive care patients is associated with the persistence of organ dysfunction (SOFA score), the occurrence of nosocomial infections and mortality. Also, it has been demonstrated that in these patients, enteral …

This description comes directly from the study's public registry record.

Talk to the study team

Mathieu Lesouhaitier, MD  ·  0033299284321  ·  mathieu.lesouhaitier@chu-rennes.fr

Jean-Marc Tadié, MD  ·  0033299284321  ·  jean-marc.tadie@chu-rennes.fr

Always discuss trial participation with your own doctor first.

Locations (5)

Rennes University Hospital - Medical ICURennes, Brittany Region, FranceRecruiting
Rennes University Hospital - Surgical ICURennes, Brittany Region, FranceTerminated
Besançon University HospitalBesançon, FranceRecruiting
Le Mans HospitalLe Mans, FranceRecruiting
Tours University HospitalTours, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT04513288