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

NCT ID: NCT06415474

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-03

Study Completion Date

2026-11-03

Brief Summary

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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.

Detailed Description

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Conditions

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Patients Undergoing Esophagectomy Patients with Severe Polytrauma Patients with Severe Neurological Lesion Patients with Abdominal Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Phenotyping arm

There is only one arm in the study. All patients (i.e. our 4 target populations) will undergo the same phenotyping procedure.

Group Type OTHER

Lymphocyte Phenotyping Procedure

Intervention Type 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.

Interventions

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Lymphocyte 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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


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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Brest

Brest, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Etienne BOTQUELEN, MD

Role: CONTACT

02 98 34 72 88

Facility Contacts

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Etienne BOTQUELEN, MD

Role: primary

02 98 34 72 88

Other Identifiers

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29BRC23.0109

Identifier Type: -

Identifier Source: org_study_id

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