Non-invasive vagus nerve stimulation for treating sepsis in intensive care patients
Randomized Pilot Study Evaluating the Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care.
This study is testing whether a new non-invasive treatment using vagus nerve stimulation can help adult patients in intensive care who are suffering from sepsis feel better and avoid serious complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Garches) |
| Trial ID | NCT04774705 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of non-invasive vagus nerve stimulation as an additional treatment for patients suffering from sepsis in intensive care. It aims to assess whether this intervention can mitigate the severe complications associated with sepsis, such as multi-organ failure and cognitive decline. Patients will be randomly assigned to receive either the vagus nerve stimulation or a placebo, allowing for a comparison of outcomes. The study focuses on adult patients who have been diagnosed with sepsis for at least 24 hours and are hospitalized in an intensive care setting.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are hospitalized in intensive care with a diagnosis of sepsis for at least 24 hours.
Not a fit: Patients with severe agitation, brain death, or those with certain medical conditions like heart disease or asthma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and reduce long-term cognitive decline in sepsis patients.
How similar studies have performed: While the approach of using vagus nerve stimulation is gaining interest, this specific application in sepsis treatment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age\> 18 years old * Adult man or woman, hospitalized in intensive care, presenting with sepsis for at least 24 hours according to the diagnostic criteria (Singer et al., 2016). * Informed consent signed by patient or family member/trusted support person * In an emergency situation, in the absence of family members/trusted family/trusted support person Exclusion Criteria: * Patient under guardianship or curatorship * Patient in a severe state of agitation. * Patient in a state of brain death or active limitation of treatment. * Multiple trauma patient, with multiple fractures of the skull. * Refusal to participate in the study or to sign the informed consent by the patient or his loved one, * Pregnant or breastfeeding woman, * No affiliation to a social security scheme. * Patient with cochlear implant * Patient with heart disease * Patient with asthma
Where this trial is running
Garches
- Raymond Poincaré Hospital — Garches, France (Recruiting)
Study contacts
- Study coordinator: Eric AZABOU
- Email: eric.azabou@aphp.fr
- Phone: +331 47 10 79 40
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.