Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513288
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2020-08-11
Brief Title:
ICITRU Randomized Trial of Immunonutrition With L-citrulline in Patients Hospitalized in Intensive Care for Sepsis or Septic Shock
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
ICITRU Randomized Trial of Immunonutrition With L-citrulline in Patients Hospitalized in Intensive Care for Sepsis or Septic Shock
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICITRU
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 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 administration of ARG was not deleterious and increased ornithine synthesis suggesting a preferential use of ARG via the arginases route without significant increase in argininaemia or effect on immune functions L-citrulline CIT an endogenous precursor of ARG constitutes an interesting alternative for increasing the availability of ARG Sponsor recent data demonstrate that the administration of CIT in intensive care is not deleterious and that it very significantly reduces mortality in an animal model of sepsis corrects hypoargininemia with convincing data on immunological parameters such as lymphopenia which is associated with mortality organ dysfunction and the occurrence of nosocomial infections The availability of ARG directly impacts the mitochondrial metabolism of T lymphocytes and their function Our hypothesis is therefore that CIT supplementation is more effective than administration of ARG in correcting hypoargininemia reducing lymphocyte dysfunction correcting immunosuppression and organ dysfunction in septic patients admitted to intensive care
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 administration of ARG was not deleterious and increased ornithine synthesis suggesting a preferential use of ARG via the arginases route without significant increase in argininaemia or effect on immune functions L-citrulline CIT an endogenous precursor of ARG constitutes an interesting alternative for increasing the availability of ARG Sponsor recent data demonstrate that the administration of CIT in intensive care is not deleterious and that it very significantly reduces mortality in an animal model of sepsis corrects hypoargininemia with convincing data on immunological parameters such as lymphopenia which is associated with mortality organ dysfunction and the occurrence of nosocomial infections The availability of ARG directly impacts the mitochondrial metabolism of T lymphocytes and their function Our hypothesis is therefore that CIT supplementation is more effective than administration of ARG in correcting hypoargininemia reducing lymphocyte dysfunction correcting immunosuppression and organ dysfunction in septic patients admitted to intensive care
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 lymphocyte number and phenotype apoptosis and lymphocyte proliferation and mitochondrial function and T lymphocyte repertoire will only be carried out on patients included in Rennes 60 patients
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 lymphocyte number and phenotype apoptosis and lymphocyte proliferation and mitochondrial function and T lymphocyte repertoire will only be carried out on patients included in Rennes 60 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A01804-35 | OTHER | ID RCB | None |