NCT04288635 Impact of Metabolite Supplementation to Restore Mitochondrial Dysfunction During Septic Shock: a Preclinical Study
| NCT ID | NCT04288635 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Septic Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2020-07-09 |
| Primary Completion | 2027-07-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2020-07-09 with a primary completion date of 2027-07-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Julien DEMISELLE, MD
PRINCIPAL INVESTIGATOR
University Hospital of Angers
Frequently Asked Questions
Who can join the NCT04288635 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04288635 currently recruiting?
Yes, NCT04288635 is actively recruiting participants. Contact the research team at Julien.Demiselle@chu-angers.fr for enrollment information.
Where is the NCT04288635 trial being conducted?
This trial is being conducted at Angers, France.
Who is sponsoring the NCT04288635 clinical trial?
NCT04288635 is sponsored by University Hospital, Angers. The principal investigator is Julien DEMISELLE, MD at University Hospital of Angers. The trial plans to enroll 55 participants.