Using L-citrulline for immunonutrition in ICU patients with sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rennes University Hospital - Medical ICU
  Rennes, Brittany Region, France Recruiting
• Besançon University Hospital
  Besançon, France Recruiting
• Le Mans Hospital
  Le Mans, France Recruiting
• Tours University Hospital
  Tours, France Recruiting
• Rennes University Hospital - Surgical ICU
  Rennes, Brittany Region, France Terminated

Study contacts

• Study coordinator: Mathieu Lesouhaitier, MD
• Email: mathieu.lesouhaitier@chu-rennes.fr
• Phone: 0033299284321

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Non-invasive hemodynamic guidance for sepsis care on medical wards

  This trial tests whether guiding fluid and vasopressor therapy for sepsis using non-invasive hemodynamic measurements works better than standard care.

  Recruiting at 2 sites Regione del Veneto - AULSS n. 7 Pedemontana · Pisa, Pisa and 1 other locations · NCT07863323

• Personalized Fluid Resuscitation in the Emergency Department

  This pilot test checks if a quick, non-invasive stroke-volume assessment can help ED doctors tailor IV fluids for septic patients with low blood pressure.

  Recruiting Intermountain Health Care, Inc. · Murray, Utah · NCT07779720

• Discordance between capillary refill time and oxygen use in septic shock

  This study tests whether some septic shock patients can have a normal capillary refill time but still lack tissue oxygen use, to see if that mismatch relates to 28-day survival.

  Recruiting Istanbul University - Cerrahpasa · Istanbul · NCT07774962

• Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock

  This trial tests whether keeping magnesium levels at the upper end of normal can reduce the amount and duration of norepinephrine needed in adults with septic shock.

  Recruiting Alexandria University · Alexandria, Alexandria Governorate · NCT07716956

• Cortisol Levels and Mortality in Septic Shock ICU Patients

  This study tests whether cortisol levels can predict death or recovery in adults with sepsis or septic shock in the ICU.

  Recruiting Ankara Etlik City Hospital · Ankara · NCT07582926

• oXiris hemofilter use for adults with septic shock and kidney failure

  This study tests whether using the oXiris hemofilter during continuous dialysis helps adults with septic shock and acute kidney injury survive and stabilize faster.

  Recruiting Seoul National University Bundang Hospital · Seongnam-si, Gyeonggi-do · NCT07539883

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.