An observational study in Septic Shock and Multiple Organ Failure, sponsored by University Hospital, Angers. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by University Hospital, Angers · Observational
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.
In this prospective study, the investigators will include patients admitted to the medical ICU of Angers University Hospital and meeting the SEPSIS-3 criteria for the definition of septic shock (Sequential Organ Failure Assessment (SOFA) score > 2, hyperlactatemia > 2 mmol/L and sepsis).
Blood samples will be collected during the usual care of initial resuscitation and analyzed in the laboratory INSERM (Institut national de la santé et de la recherche médicale) U1232 (University Hospital of Angers).
Mitochondrial metabolism will be analyzed in freshly isolated PBMC and after culture for 1-3 days, with or without the addition of selected metabolites to the cell culture medium.
The evolution of ketogenesis, mitochondrial function, acidobasic status will be assessed across the time (blood samples at day 2 and 4).
Survival, 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 will be recorded.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 55 is below the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients aged 18 or more who meet the SEPSIS-3 criteria for septic shock : a presumed sepsis, with persisting hypotension requiring vasopressors to maintain mean arterial pressure > 65 mmHg and having a serum lactate > 2 mmol/L despite adequate fluid expansion, admitted to the medical ICU of Angers University Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients aged more than 18, admitted in University Hospital of Angers, who meet the full criteria of septic shock
Biological: Whole blood samples
Whole blood samples at admission, from day one to three after admission
Change in mitochondrial metabolism (mitochondrial membrane depolarization and respiration) with the supplementation of metabolite in the cell culture medium
Using Fluorescence-activated cell sorting system to assess the membrane depolarization of the mitochondria and Oroboros system for mitochondrial respiration
Time frame: Day 0 (whole blood after cells separation), Day 1-3 after cell culture
Overall survival at 28 days
Survival of patients after ICU admission
Time frame: Day 28
Change in organs failure
Using the Sequential Organ Failure Assessment Score
Time frame: From Day 0 to Day 4
Change and correlation between lactic acidosis, ketogenesis and mitochondrial function evolutions
biochemical analysis of blood samples, assessment of mitochondrial metabolism (quantitative and qualitative analysis).
Time frame: From Day 1 to Day 3
Need for renal replacement therapy during the ICU stay
Need for renal replacement therapy and its duration
Time frame: From Day 1 to Day 28
Need for vasopressors during the ICU stay
Need for vasopressors during the ICU stay and its duration
Time frame: From Day 1 to Day 28
Need for mechanical ventilation during the ICU stay
Need for mechanical ventilation during the ICU stay and its duration
Time frame: From Day 1 to Day 28
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2020 (actual). Primary completion is estimated for Jul 2027, 84 months after the start.
Of 189 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 84 months is above that.
Counting every sponsor, half of 202 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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