Septicaemia Clinical Trial
— MyelochondriaOfficial title:
Monitoring of the Mitochondrial Function of Circulating Myeloid Cells in Patients Hospitalized in the Intensive Care Unit of Dijon University Hospital
NCT number | NCT04439617 |
Other study ID # | QUENOT 2019 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2019 |
Est. completion date | March 30, 2020 |
Verified date | June 2020 |
Source | Centre Hospitalier Universitaire Dijon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | March 30, 2020 |
Est. primary completion date | January 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
France | Chu Dijon Bourgogne | Dijon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Dijon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of mitophagy in circulating monocytes | 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) | <24 hours after hospitalization in intensive care |
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