Status:
RECRUITING
ICITRU : Randomized Trial of Immunonutrition With L-citrulline in Patients Hospitalized in Intensive Care for Sepsis or Septic Shock
Lead Sponsor:
Rennes University Hospital
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 immunosuppressi...
Detailed Description
Strategy : Enteral administration of citrulline for 5 days versus iso-nitrogenous placebo. Amino acid assay and immunological parameters (monocytic expression of HLA-DR, MDSCs, cytokines / chemokines...
Eligibility Criteria
Inclusion
- 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
- 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
- \- 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).
Key Trial Info
Start Date :
May 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04513288
Start Date
May 20 2022
End Date
November 20 2026
Last Update
October 8 2024
Active Locations (5)
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1
Rennes University Hospital - Medical ICU
Rennes, Brittany Region, France, 35033
2
Rennes University Hospital - Surgical ICU
Rennes, Brittany Region, France, 35033
3
Besançon University Hospital
Besançon, France, 25000
4
Le Mans Hospital
Le Mans, France, 72037