Monitoring Mitophagy In Myeloid Cells Upon Intensive Care

NCT05040503 | Completed

• 1 other identifier: QUENOT 2020-2
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Level of mitophagy

  at admission and at 24 hours post-admission

Study Arms (4)

Patients without sepsis

ACTIVE COMPARATOR

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

Biological: Blood sampling at inclusion; Biological: Blood sampling at 24 hours; Other: Data collection

Patients with sepsis

EXPERIMENTAL

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

Biological: Blood sampling at inclusion; Biological: Blood sampling at 24 hours; Other: Data collection

Patients with septic shock

EXPERIMENTAL

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

Biological: Blood sampling at inclusion; Biological: Blood sampling at 24 hours; Other: Data collection

Healthy volunteers

ACTIVE COMPARATOR

Biological: Blood sampling at inclusion; Other: Data collection

Interventions

Blood sampling at inclusion BIOLOGICAL

Sampling of 2 tubes of 3 ml: * patient: H0: 0-6h post-admission * healthy volunteer: at inclusion

Healthy volunteers; Patients with sepsis; Patients with septic shock; Patients without sepsis

Blood sampling at 24 hours BIOLOGICAL

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

Patients with sepsis; Patients with septic shock; Patients without sepsis

Data collection OTHER

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

Healthy volunteers; Patients with sepsis; Patients with septic shock; Patients without sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients receiving therapy known to modulate mitochondrial function, mitochondrial biogenesis or mitophagy (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil)
• Patients with COVID-19

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

Location

MeSH Terms

Conditions

Sepsis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 10, 2021
• Study Start: August 25, 2021
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)