Clinical Trial

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

Study acronym: MEFDASE
Recruiting
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-07-09 -> 2027-07-09 2026-08-11
minor Completion pushed: 2026-08-09 -> 2027-08-09 2026-08-11
Trial Details
NCT Number NCT04288635
Lead Sponsor University Hospital, Angers
Conditions Septic Shock, Multiple Organ Failure
Enrollment 55 participants
Start Date 2020-07-09
Primary Completion 2027-07-09 (estimated)
Study Completion 2027-08-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-10