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Monitoring Mitophagy In Myeloid Cells Upon Intensive Care (MIMIC)

Primary Purpose

Septicemia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling at inclusion
Blood sampling at 24 hours
Data collection
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Septicemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chu Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

Patients without sepsis

Patients with sepsis

Patients with septic shock

Healthy volunteers

Arm Description

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

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

Outcomes

Primary Outcome Measures

Level of mitophagy

Secondary Outcome Measures

Full Information

First Posted
August 30, 2021
Last Updated
July 24, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT05040503
Brief Title
Monitoring Mitophagy In Myeloid Cells Upon Intensive Care
Acronym
MIMIC
Official Title
Monitoring Mitophagy In Myeloid Cells Upon Intensive Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septicemia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients without sepsis
Arm Type
Active Comparator
Arm Description
patient without sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Arm Title
Patients with sepsis
Arm Type
Experimental
Arm Description
Patients with sepsis admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Arm Title
Patients with septic shock
Arm Type
Experimental
Arm Description
Patients with septic shock admitted to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Blood sampling at inclusion
Intervention Description
Sampling of 2 tubes of 3 ml: patient: H0: 0-6h post-admission healthy volunteer: at inclusion
Intervention Type
Biological
Intervention Name(s)
Blood sampling at 24 hours
Intervention Description
Collection of 2 tubes of 3 ml (H24: 24-30h post-admission)
Intervention Type
Other
Intervention Name(s)
Data collection
Intervention Description
clinical and biological medical data for patients and general health data for healthy volunteers
Primary Outcome Measure Information:
Title
Level of mitophagy
Time Frame
at admission and at 24 hours post-admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Pierre QUENOT
Phone
03 80 29 36 85
Email
jean-pierre.quenot@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre QUENOT
Phone
03 80 29 36 85
Email
jean-pierre.quenot@chu-dijon.fr

12. IPD Sharing Statement

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Monitoring Mitophagy In Myeloid Cells Upon Intensive Care

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