Monitoring Mitophagy In Myeloid Cells Upon Intensive Care

Not Applicable

Recruiting

• Conditions: Septicemia
• Interventions: Biological: Blood sampling at inclusion; Other: Data collection; Biological: Blood sampling at 24 hours

• Registration Number: NCT05040503
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-25
• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-10
• Status Verified: 2023-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Data collection	-
Patients without sepsis	Blood sampling at inclusion	patient without sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Patients with septic shock	Data collection	Patients with septic shock admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Healthy volunteers	Blood sampling at inclusion	-
Patients with sepsis	Blood sampling at inclusion	Patients with sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Patients without sepsis	Blood sampling at 24 hours	patient without sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Patients without sepsis	Data collection	patient without sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Patients with sepsis	Blood sampling at 24 hours	Patients with sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Patients with septic shock	Blood sampling at inclusion	Patients with septic shock admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Patients with sepsis	Data collection	Patients with sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Patients with septic shock	Blood sampling at 24 hours	Patients with septic shock admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

Primary Outcome Measures

Name	Time	Method
Level of mitophagy	at admission and at 24 hours post-admission

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France