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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients Undergoing Esophagectomy; Patients With Severe Polytrauma; Patients With Severe Neurological Lesion; Patients With Abdominal Infection
• Intervention / Treatment: Procedure: Lymphocyte Phenotyping Procedure

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphocytes numbers variation	- 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)	Day 0
Lymphocytes numbers variation	- Numbers of various lymphocytes (LT, LB, NK and their subclasses) at D7 according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)	Day 7
Lymphocytes numbers variation	- Numbers of various lymphocytes (LT, LB, NK and their subclasses) at discharge according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)	Immediately upon prescribed discharge date
Lymphocytes numbers variation	- Numbers of various lymphocytes (LT, LB, NK and their subclasses) at diagnosis of infection according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)	Immediately after diagnosis of infection
Lymphocytes numbers variation	- Numbers of various lymphocytes (LT, LB, NK and their subclasses) at half duration of infection's treatment according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)	At the midpoint of the prescribed antibiotic course
Lymphocytes percentages variation	- 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)	Day 0
Lymphocytes percentages variation	- Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at D7 according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)	Day 7
Lymphocytes percentages variation	- Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at discharge according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)	Immediately upon prescribed discharge date
Lymphocytes percentages variation	- Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at day of diagnosis according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)	Immediately after diagnosis of infection
Lymphocytes percentages variation	- Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at half duration of infection's treatment according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)	At the midpoint of the prescribed antibiotic course

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphocytes percentages variation in case of infection	Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at D0	Day 0
Lymphocytes percentages variation in case of infection	Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at onset of infection	At the onset of symptoms of infection
Lymphocytes percentages variation in case of infection	Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at resolution of infection	Immediately following resolution of infection
Lymphocytes numbers variation in case of infection	Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at D0	Day 0
Lymphocytes numbers variation in case of infection	Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at onset of infection	Immediately after diagnosis of infection
Lymphocytes numbers variation in case of infection	Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at resolution of infection	Immediately following resolution of infection

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Infections; Communicable Diseases; Intraabdominal Infections; Multiple Trauma
• Other Study ID Numbers: 29BRC23.0109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No