Monitoring Mitophagy In Myeloid Cells Upon Intensive Care

NCT ID: NCT05040503

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-25
• Study Completion Date: 2025-03-13

Brief Summary

Severe infections (sepsis) are a frequent cause of admission to the intensive care unit. Sepsis represent a significant risk for the health of patients in the short and medium term. Sepsis are notably linked to a change in the function of immune cells. In some patients, a state of pseudo-dormancy of monocyte and macrophage immune cells, called myeloid cell immunosuppression, is observed. This situation, which leads to a worsening of the infection, must be avoided because it represents a danger for the patient, even during antibiotic therapy. At present, these events are still very poorly understood. Research is needed to understand how the immunosuppression of myeloid cells occurs in order to adapt existing treatments or to find new ones.

Laboratory work on animal models of sepsis has shown that this state of myeloid cell immunosuppression is closely linked to a modification of energy production by myeloid cells (monocytes and macrophages). The function of the mitochondria ("energy factory" of the cells) in these cells is impaired. Thus, restoring mitochondrial function in myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells during severe sepsis.

The aim of this study is to verify whether alterations in mitochondrial function in myeloid cells occur in both patients with and without bacterial infection.

Conditions

Septicemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients without sepsis

patient without sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

Group Type: ACTIVE_COMPARATOR

Blood sampling at inclusion

Intervention Type: BIOLOGICAL

Sampling of 2 tubes of 3 ml:

• patient: H0: 0-6h post-admission
• healthy volunteer: at inclusion

Blood sampling at 24 hours

Intervention Type: BIOLOGICAL

Collection of 2 tubes of 3 ml (H24: 24-30h post-admission)

Data collection

Intervention Type: OTHER

clinical and biological medical data for patients and general health data for healthy volunteers

Patients with sepsis

Patients with sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

Group Type: EXPERIMENTAL

Blood sampling at inclusion

Intervention Type: BIOLOGICAL

Sampling of 2 tubes of 3 ml:

• patient: H0: 0-6h post-admission
• healthy volunteer: at inclusion

Blood sampling at 24 hours

Intervention Type: BIOLOGICAL

Collection of 2 tubes of 3 ml (H24: 24-30h post-admission)

Data collection

Intervention Type: OTHER

clinical and biological medical data for patients and general health data for healthy volunteers

Patients with septic shock

Patients with septic shock admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

Group Type: EXPERIMENTAL

Blood sampling at inclusion

Intervention Type: BIOLOGICAL

Sampling of 2 tubes of 3 ml:

• patient: H0: 0-6h post-admission
• healthy volunteer: at inclusion

Blood sampling at 24 hours

Intervention Type: BIOLOGICAL

Collection of 2 tubes of 3 ml (H24: 24-30h post-admission)

Data collection

Intervention Type: OTHER

clinical and biological medical data for patients and general health data for healthy volunteers

Healthy volunteers

Group Type: ACTIVE_COMPARATOR

Blood sampling at inclusion

Intervention Type: BIOLOGICAL

Sampling of 2 tubes of 3 ml:

• patient: H0: 0-6h post-admission
• healthy volunteer: at inclusion

Data collection

Intervention Type: OTHER

clinical and biological medical data for patients and general health data for healthy volunteers

Interventions

Blood sampling at inclusion

Sampling of 2 tubes of 3 ml:

• patient: H0: 0-6h post-admission
• healthy volunteer: at inclusion

Intervention Type: BIOLOGICAL

Blood sampling at 24 hours

Collection of 2 tubes of 3 ml (H24: 24-30h post-admission)

Intervention Type: BIOLOGICAL

Data collection

clinical and biological medical data for patients and general health data for healthy volunteers

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Criteria common to all 4 groups:

• Patient (and/or trusted person/health care proxy or relative) or volunteer who provided oral consent after receiving information about the study, or patient included in emergency situation
• Age ≥ 18 years

Common criteria for patients

• Admission to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

Exclusion Criteria

• Person not affiliated to national health insurance
• Person subject to a measure of legal protection (curatorship, guardianship)
• Person subject to limited judicial protection
• Pregnancy or breastfeeding
• Known primary or secondary immune deficiency (radiotherapy, chemotherapy, immunosuppressive treatment or systemic corticosteroid therapy in the 3 months preceding inclusion (> 0.15 mg/kg/d of prednisone equivalent for more than 2 weeks or "bolus" greater than 2mg/kg/d of prednisone equivalent), HIV infection, primary cellular immune deficiency)
• Patients hospitalized within 3 months prior to inclusion for sepsis.
• Patients receiving therapy known to modulate mitochondrial function, mitochondrial biogenesis or mitophagy (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil)
• Patients with COVID-19

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourgogne

Dijon, , France

Countries

France

Other Identifiers

QUENOT 2020-2

Identifier Type: -

Identifier Source: org_study_id