RecruitingNCT04288635

Impact of Metabolite Supplementation to Restore Mitochondrial Dysfunction During Septic Shock: a Preclinical Study

Impact of Metabolite Supplementation to Restore Mitochondrial Dysfunction During Septic Shock: a Preclinical Study: MEFDASE Study


Sponsor

University Hospital, Angers

Enrollment

55 participants

Start Date

Jul 9, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

Septic shock is defined as a subset of sepsis with severe metabolism alterations, leading to organ failure. Septic shock is associated with a high mortality, around 40% according to the SEPSIS 3 definition. Metabolic alterations are responsible for lactic acidosis, and results in mitochondrial dysfunction. This study aims at evaluate the impact of exogenous metabolites on restoring mitochondrial function in septic shock patients with lactate acidosis. Mitochondrial metabolism (quantitative analysis, mitochondrial function) in intact Peripheral Blood Mononuclear Cells (PBMC) will be isolate and analyse from patients at the early phase of septic shock (admission), at day 2 and 4. Participant's medical history will be recorded: renal and liver metabolism, severity scores and outcomes and the need for supportive care in the intensive care unit (ICU) until 28 days after admission. Furthermore, the investigators will evaluate wether selected metabolites added to the cell culture medium may improve mitochondrial metabolism.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This preclinical research study is examining whether supplementing specific metabolites (small molecules involved in energy production) can restore mitochondrial function in patients suffering from septic shock. In septic shock, cells lose their ability to produce energy efficiently due to mitochondrial dysfunction, which contributes to organ failure. By restoring these key metabolites, researchers hope to improve cell survival and patient outcomes. You may be eligible if: - You are 18 years or older - You meet the SEPSIS-3 definition of septic shock: presumed sepsis with persistent low blood pressure requiring vasopressors and blood lactate above 2 mmol/L despite adequate fluid treatment - You are admitted to the ICU at Angers University Hospital (France) You may NOT be eligible if: - You are under 18 years old - You are subject to legal protection measures - You or your family have refused participation - You have a pre-existing mitochondrial disease - You have bone marrow aplasia - You are pregnant or recently gave birth Talk to your intensive care team about this study if you or a family member is hospitalized with septic shock at Angers University Hospital in France.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALWhole blood samples

Whole blood samples at admission, from day one to three after admission


Locations(1)

CHU

Angers, Maine et Loire, France

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NCT04288635


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