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Evolution of the Lymphocyte Phenotype in Patients With Infection in Intensive Care Unit

Evolution of the Lymphocyte Phenotype in Patients With Infection in Intensive Care Unit

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06415474
Acronym
REAPHEN
Enrollment
38
Registered
2024-05-16
Start date
2024-10-03
Completion date
2025-04-08
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Esophagectomy, Patients With Abdominal Infection, Patients With Severe Neurological Lesion, Patients With Severe Polytrauma

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.

Interventions

PROCEDURELymphocyte Phenotyping Procedure

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 will be used. 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. It is important to note that phenotyping is not routinely performed as part of routine care. An additional tube is therefore taken specifically for this analysis, but this is done without the need for an additional puncture.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lymphocytes numbers variationDay 0\- Numbers of various lymphocytes (LT, LB, NK and their subclasses) at D0 according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)
Lymphocytes percentages variationDay 0\- Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at D0 according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)

Secondary

MeasureTime frameDescription
Lymphocytes percentages variation in case of infectionDay 0Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at D0
Lymphocytes numbers variation in case of infectionDay 0Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at D0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026