Evaluating metabolite supplementation to improve mitochondrial function in septic shock patients
Official title: Impact of Metabolite Supplementation to Restore Mitochondrial Dysfunction During Septic Shock: a Preclinical Study: MEFDASE Study
Run by University Hospital, Angers · NCT04288635 · Data updated 2026-11-12
This study is testing if adding certain nutrients can help improve the energy production in patients with septic shock and see how it affects their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | University Hospital, Angers Government |
| Locations | 1 site (Angers, Maine et Loire) |
| Status | Recruiting |
| Started | July 9, 2020 |
| Main results expected | July 9, 2027 |
| Study ends | August 9, 2027 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT04288635 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who meet the SEPSIS-3 criteria for septic shock and are admitted to the ICU.
✕Probably not a fit
Patients who may not benefit include those under 18, those with preexisting mitochondrial diseases, or those who refuse participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the effects of exogenous metabolites on mitochondrial function in patients experiencing septic shock, a critical condition characterized by severe metabolic alterations and high mortality rates. Patients admitted to the medical ICU at Angers University Hospital will have their blood samples collected and analyzed at various time points to assess mitochondrial metabolism and function. The study aims to correlate these metabolic changes with clinical outcomes, including survival and the need for intensive care support. The research will focus on patients meeting specific criteria for septic shock as defined by the SEPSIS-3 guidelines.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from septic shock, potentially reducing mortality and organ failure.
How similar studies have gone: While the approach of using metabolite supplementation is innovative, similar studies focusing on metabolic interventions in critical care settings have shown promise, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients aged 18 or more * Patients with criteria for septic shock according to SEPSIS 3 definition (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 in the ICU of Angers University Hospital Exclusion Criteria: * Minor patients (aged less 18) * Patient subject to legal protection measures * Refusal of the patient or his family * Preexisting mitochondrial disease * Patient with aplasia * Pregnant or parturient women
Where it's running
-
Chu
Angers, Maine et Loire, France Recruiting
Study contacts
- Principal investigator: Julien DEMISELLE, MD — University Hospital of Angers
- Study coordinator: Julien DEMISELLE, MD
- Email: Julien.Demiselle@chu-angers.fr
- Phone: +33 2 41 35 58 65
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Adjunctive Fludrocortisone in Septic Shock on Hydrocortisone
In septic shock, this trial tests whether adding fludrocortisone (50 mcg or 100 mcg daily) to hydrocortisone improves survival and recovery compared with placebo.
-
Non-invasive hemodynamic guidance for sepsis care on medical wards
This trial tests whether guiding fluid and vasopressor therapy for sepsis using non-invasive hemodynamic measurements works better than standard care.
-
Reducing Endotoxin Burden in Septic Shock Patients on CRRT with the oXiris Filter
This trial tests whether using the oXiris hemofilter during continuous kidney replacement helps lower endotoxin levels in adults with septic shock who need CRRT.
-
Personalized Fluid Resuscitation in the Emergency Department
This pilot test checks if a quick, non-invasive stroke-volume assessment can help ED doctors tailor IV fluids for septic patients with low blood pressure.
-
Discordance between capillary refill time and oxygen use in septic shock
This study tests whether some septic shock patients can have a normal capillary refill time but still lack tissue oxygen use, to see if that mismatch relates to 28-day survival.
-
Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock
This trial tests whether keeping magnesium levels at the upper end of normal can reduce the amount and duration of norepinephrine needed in adults with septic shock.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.