Patients Undergoing EsophagectomyREAPHENNCT06415474
Evolution of the Lymphocyte Phenotype in Patients With Infection in Intensive Care Unit
A study testing Lymphocyte Phenotyping Procedure in people with Patients Undergoing Esophagectomy and Patients With Severe Polytrauma, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Esophagectomy, Patients With Severe Polytrauma, Patients With Severe Neurological Lesion
- What is being tested?
- Lymphocyte Phenotyping Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2024to 8 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Patients Undergoing Esophagectomy, Patients With Severe Polytrauma, Patients With Severe Neurological Lesion, Patients With Abdominal Infection
- Being tested
- Lymphocyte Phenotyping Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphocyte Phenotyping ProcedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Phenotyping arm | Other | There is only one arm in the study. All patients (i.e. our 4 target populations) will undergo the same phenotyping procedure. Receives: Procedure: Lymphocyte Phenotyping Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At the midpoint of the prescribed antibiotic course
Secondary outcomes (6)
Lymphocytes percentages variation in case of infection
Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at D0
Measured: Day 0
Lymphocytes percentages variation in case of infection
Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at onset of infection
Measured: 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
Measured: 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
Measured: Day 0
Lymphocytes numbers variation in case of infection
Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at onset of infection
Measured: 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
Measured: Immediately following resolution of infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start3 Oct 2024
- Primary completion8 Apr 2025
- Study completion8 Apr 2025
Why it stopped: Étude exploratoire sans calcul d'effectif (80 fixé arbitrairement, littérature absente). 38/80 inclus, suffisant pour de l'exploratoire. Données de bonne qualité malgré la difficulté des prélèvements à J0.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing EsophagectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415474
- Sponsor's protocol ID
- 29BRC23.0109
- Acronym
- REAPHEN
- Status last verified
- Jun 2026
- First submitted
- 26 Apr 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the Lymphocyte Phenotype in Patients With Infection in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06415474
- Acronym / sponsor ID
- REAPHEN / 29BRC23.0109
- Conditions
- Patients Undergoing Esophagectomy, Patients With Severe Polytrauma, Patients With Severe Neurological Lesion, Patients With Abdominal Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Étude exploratoire sans calcul d'effectif (80 fixé arbitrairement, littérature absente). 38/80 inclus, suffisant pour de l'exploratoire. Données de bonne qualité malgré la difficulté des prélèvements à J0.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phenotyping arm | Other | Procedure: Lymphocyte Phenotyping ProcedureThere is only one arm in the study. All patients (i.e. our 4 target populations) will undergo the same phenotyping procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphocyte Phenotyping ProcedureFor 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. | Procedure or surgery | Phenotyping arm |
Primary outcome
Lymphocytes numbers variation
Time frame: Day 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 numbers variation
Time frame: Day 7
- 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)
Lymphocytes numbers variation
Time frame: Immediately upon prescribed discharge date
- 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)
Lymphocytes numbers variation
Time frame: Immediately after diagnosis of infection
- 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)
Lymphocytes numbers variation
Time frame: At the midpoint of the prescribed antibiotic course
- 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)
Lymphocytes percentages variation
Time frame: Day 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)
Lymphocytes percentages variation
Time frame: Day 7
- 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)
Lymphocytes percentages variation
Time frame: Immediately upon prescribed discharge date
- 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)
Lymphocytes percentages variation
Time frame: Immediately after diagnosis of infection
- 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)
Lymphocytes percentages variation
Time frame: At the midpoint of the prescribed antibiotic course
- 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)
6 secondary outcomes
Lymphocytes percentages variation in case of infection
Time frame: Day 0
Lymphocytes percentages variation in case of infection
Time frame: At the onset of symptoms of infection
Lymphocytes percentages variation in case of infection
Time frame: Immediately following resolution of infection
Lymphocytes numbers variation in case of infection
Time frame: Day 0
Lymphocytes numbers variation in case of infection
Time frame: Immediately after diagnosis of infection
Lymphocytes numbers variation in case of infection
Time frame: Immediately following resolution of infection
Results and safety
The study was stopped early (reason given: Étude exploratoire sans calcul d'effectif (80 fixé arbitrairement, littérature absente). 38/80 inclus, suffisant pour de l'exploratoire. Données de bonne qualité malgré la difficulté des prélèvements à J0.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphocyte Phenotyping Procedure in people with Patients Undergoing Esophagectomy and Patients With Severe Polytrauma, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Étude exploratoire sans calcul d'effectif (80 fixé arbitrairement, littérature absente). 38/80 inclus, suffisant pour de l'exploratoire. Données de bonne qualité malgré la difficulté des prélèvements à J0.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphocytes numbers variation (time frame: Day 0). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.