Clinical trial NCT06415474: Evolution of the Lymphocyte Phenotype in Patients with Infection in Intensive Care Unit
Official title: Evolution of the Lymphocyte Phenotype in Patients with Infection in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patients Undergoing Esophagectomy
Patients with Severe Polytrauma
Patients with Severe Neurological Lesion
Patients with Abdominal Infection
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: For all patients, lymphocyte phenotyping will be performed on biological samples taken on D0, D7 and the day of discharge. In case of infection, phenotyping will also be performed on the day of infection diagnosis and on the day corresponding to half the duration of antibiotic therapy.

For phenotyping, only 1.5 mL (0.5 mL per analysis) will be used (if no infection). In case of infection, an additional 1mL will be collected (0.5mL on the day of inclusion diagnosis and 0.5 mL on the day corresponding to half the duration of antibiotic therapy). Blood is collected during sampling, which takes place several times a day as part of the standard management of these patients.
Primary purpose: BASIC_SCIENCE

Brief summary: Patients admitted for polytrauma, severe neurological injury, post-operative monitoring or sepsis/septic shock present with significant inflammation, leading to immunoparalysis, which is responsible for infection, particularly prolonged infection. A study of their lymphocyte phenotype over time could help explore the phenomenon of immunoparalysis.


Eligibility criteria: Inclusion criteria:

* Postoperative esophagectomy surveillance within the last 24 hours.
* Patients with intra-abdominal infection
* Neurological patients with intubation planned for more than 24 hours (subarachnoid hemorrhage with coma, severe head trauma, ischemic or hemorrhagic stroke with coma).
* Polytrauma with intubation planned for more than 24 hours
* Patient aged 18 and over
* Patient with social security coverage

Non-inclusion criteria :

* Hereditary immune deficiency HIV-AIDS
* Malignant hemopathies
* Immunosuppressive treatment other than corticosteroid therapy or chemotherapy
* Patient under legal protection
* Pregnant or breast-feeding women

Primary outcomes:
measure: Lymphocytes numbers variation
timeFrame: Day 0
measure: Lymphocytes numbers variation
timeFrame: Day 7
measure: Lymphocytes numbers variation
timeFrame: Immediately upon prescribed discharge date
measure: Lymphocytes numbers variation
timeFrame: Immediately after diagnosis of infection
measure: Lymphocytes numbers variation
timeFrame: At the midpoint of the prescribed antibiotic course
measure: Lymphocytes percentages variation
timeFrame: Day 0
measure: Lymphocytes percentages variation
timeFrame: Day 7
measure: Lymphocytes percentages variation
timeFrame: Immediately upon prescribed discharge date
measure: Lymphocytes percentages variation
timeFrame: Immediately after diagnosis of infection
measure: Lymphocytes percentages variation
timeFrame: At the midpoint of the prescribed antibiotic course
Secondary outcomes:
measure: Lymphocytes percentages variation in case of infection
timeFrame: Day 0
measure: Lymphocytes percentages variation in case of infection
timeFrame: At the onset of symptoms of infection
measure: Lymphocytes percentages variation in case of infection
timeFrame: Immediately following resolution of infection
measure: Lymphocytes numbers variation in case of infection
timeFrame: Day 0
measure: Lymphocytes numbers variation in case of infection
timeFrame: Immediately after diagnosis of infection
measure: Lymphocytes numbers variation in case of infection
timeFrame: Immediately following resolution of infection
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References: