- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04439617
Monitoring of the Mitochondrial Function of Circulating Myeloid Cells in Patients Hospitalized in the Intensive Care Unit of Dijon University Hospital (Myelochondria)
Severe infections (sepsis) are a common cause of admission to the intensive care unit. They represent a significant health risk for patients in the short and medium term. They are particularly linked to a change in the function of immune cells. In some patients, a state of pseudo-dormancy of monocyte and macrophage-type immune cells, called immunosuppression of myeloid cells, is observed. This situation leads to a worsening of the infection, so it should be avoided because it represents a danger for the patient even when they ar receiving antibiotics. At present, these events are still very poorly understood. Research is essential to understand how this state of immunosuppression of myeloid cells is established in order to adapt existing treatments or find new ones.
Laboratory studies on animal models of septicaemia have shown that this state of immunosuppression of myeloid cells is closely linked to a change in the production of energy by myeloid cells (monocytes and macrophages). The functioning 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 septicaemia.
The objective of this study is to verify whether alterations in mitochondrial function in myeloid cells also occur in patients with bacterial infection compared to patients without bacterial infection.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Dijon, France, 21000
- Chu Dijon Bourgogne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult person who has given written consent (or consent obtained from a heath care proxy) hospitalized in an ICU with or without sepsis (with or without infection)
Exclusion Criteria:
- Person not affiliated or not benefiting from national health insurance
- Person under legal protection (curatorship, guardianship, safeguard of justice)
- Pregnant, parturient or breastfeeding woman
- Patient who was hospitalized within 3 months prior to inclusion for sepsis.
- Patients receiving known treatment for mitochondrial function modulation, mitochondrial biogenesis or mitophagy (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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sepsis patient
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use of the remaining 1-2 ml of blood in samples taken as part of routine care to study mitochondrial function
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Sepsis-free patient
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use of the remaining 1-2 ml of blood in samples taken as part of routine care to study mitochondrial function
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of mitophagy in circulating monocytes
Time Frame: <24 hours after hospitalization in intensive care
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Measurement of mitochondrial density and PINK1 protein expression by flow cytometry in circulating monocytes (total population and subpopulation of conventional, intermediate and non-conventional monocytes (CD33, CD16 and CD14 monocyte markers)
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<24 hours after hospitalization in intensive care
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QUENOT 2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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