Evaluating metabolite supplementation to improve mitochondrial function in septic shock patients
Impact of Metabolite Supplementation to Restore Mitochondrial Dysfunction During Septic Shock: a Preclinical Study: MEFDASE Study
University Hospital, Angers · NCT04288635
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 |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers (other gov) |
| Locations | 1 site (Angers, Maine et Loire) |
| Trial ID | NCT04288635 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who may not benefit include those under 18, those with preexisting mitochondrial diseases, or those who refuse participation.
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 performed: 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.
Eligibility criteria
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 this trial is running
Angers, Maine et Loire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Septic Shock, Multiple Organ Failure, mitochondrial dysfunction