Monitoring Mitophagy In Myeloid Cells Upon Intensive Care

Septicemia Clinical Trial

— MIMIC  

Official title:

Monitoring Mitophagy In Myeloid Cells Upon Intensive Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05040503
• Other study ID #: QUENOT 2020-2
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: September 2024

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Jean-Pierre QUENOT
• Phone: 03 80 29 36 85
• Email: jean-pierre.quenot[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septicemia

Intervention

Biological:
• Blood sampling at inclusion
Sampling of 2 tubes of 3 ml: patient: H0: 0-6h post-admission healthy volunteer: at inclusion
• Blood sampling at 24 hours
Collection of 2 tubes of 3 ml (H24: 24-30h post-admission)

Other:
• Data collection
clinical and biological medical data for patients and general health data for healthy volunteers

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of mitophagy		at admission and at 24 hours post-admission