## Protocol Section
### Identification Module
**NCT ID:** NCT06415474

**Acronym:** REAPHEN

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 29BRC23.0109
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Brest
### Status Module
#### Completion Date
**Date:** 2026-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Brest

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Patients Undergoing Esophagectomy

- Patients With Severe Polytrauma

- Patients With Severe Neurological Lesion

- Patients With Abdominal Infection

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Lymphocyte Phenotyping Procedure

**Label:** Phenotyping arm

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Phenotyping arm

**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 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.

**Name:** Lymphocyte Phenotyping Procedure

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** - 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)

**Measure:** Lymphocytes numbers variation

**Time Frame:** Day 0

**Description:** - 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)

**Measure:** Lymphocytes numbers variation

**Time Frame:** Day 7

**Description:** - 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)

**Measure:** Lymphocytes numbers variation

**Time Frame:** Immediately upon prescribed discharge date

**Description:** - 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)

**Measure:** Lymphocytes numbers variation

**Time Frame:** Immediately after diagnosis of infection

**Description:** - 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)

**Measure:** Lymphocytes numbers variation

**Time Frame:** At the midpoint of the prescribed antibiotic course

**Description:** - 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)

**Measure:** Lymphocytes percentages variation

**Time Frame:** Day 0

**Description:** - 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)

**Measure:** Lymphocytes percentages variation

**Time Frame:** Day 7

**Description:** - 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)

**Measure:** Lymphocytes percentages variation

**Time Frame:** Immediately upon prescribed discharge date

**Description:** - 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)

**Measure:** Lymphocytes percentages variation

**Time Frame:** Immediately after diagnosis of infection

**Description:** - 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)

**Measure:** Lymphocytes percentages variation

**Time Frame:** At the midpoint of the prescribed antibiotic course

#### Secondary Outcomes

**Description:** Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at D0

**Measure:** Lymphocytes percentages variation in case of infection

**Time Frame:** Day 0

**Description:** Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at onset of infection

**Measure:** Lymphocytes percentages variation in case of infection

**Time Frame:** At the onset of symptoms of infection

**Description:** Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at resolution of infection

**Measure:** Lymphocytes percentages variation in case of infection

**Time Frame:** Immediately following resolution of infection

**Description:** Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at D0

**Measure:** Lymphocytes numbers variation in case of infection

**Time Frame:** Day 0

**Description:** Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at onset of infection

**Measure:** Lymphocytes numbers variation in case of infection

**Time Frame:** Immediately after diagnosis of infection

**Description:** Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at resolution of infection

**Measure:** Lymphocytes numbers variation in case of infection

**Time Frame:** Immediately following resolution of infection

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M29465

- Name: Intraabdominal Infections

- Relevance: HIGH

- As Found: Abdominal Infections

- ID: M12061

- Name: Multiple Trauma

- Relevance: HIGH

- As Found: Polytrauma

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000059413

- Term: Intraabdominal Infections

- ID: D000009104

- Term: Multiple Trauma

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
