Monitoring Mitophagy In Myeloid Cells Upon Intensive Care (MIMIC)

July 24, 2023 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy volunteers
Biological: Blood sampling at inclusion

Sampling of 2 tubes of 3 ml:

  • patient: H0: 0-6h post-admission
  • healthy volunteer: at inclusion
Other: Data collection
clinical and biological medical data for patients and general health data for healthy volunteers
Active Comparator: Patients without sepsis
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

Sampling of 2 tubes of 3 ml:

  • patient: H0: 0-6h post-admission
  • healthy volunteer: at inclusion
Biological: 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
Experimental: Patients with sepsis
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

Sampling of 2 tubes of 3 ml:

  • patient: H0: 0-6h post-admission
  • healthy volunteer: at inclusion
Biological: 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
Experimental: 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
Biological: Blood sampling at inclusion

Sampling of 2 tubes of 3 ml:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of mitophagy
Time Frame: at admission and at 24 hours post-admission
at admission and at 24 hours post-admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 10, 2021

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUENOT 2020-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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