Using nerve stimulation to manage inflammation in septic shock
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
This study is testing if a new ear stimulation technique can help reduce inflammation and improve recovery in patients with septic shock.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT03992378 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of transcutaneous vagus nerve stimulation (TVNS) to regulate inflammation and autonomic imbalance in patients suffering from septic shock. The study aims to activate the cholinergic anti-inflammatory pathway through non-invasive stimulation at the tragus of the ear, potentially leading to improved outcomes in sepsis management. By targeting the autonomic nervous system, the trial seeks to address a critical gap in current treatment approaches for this life-threatening condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with septic shock who have persistent low blood pressure despite receiving adequate fluid resuscitation.
Not a fit: Patients with a history of certain heart conditions, autonomic dysfunction, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce inflammation and improve survival rates in patients with septic shock.
How similar studies have performed: While the use of vagus nerve stimulation is a novel approach in the context of sepsis, similar studies in other inflammatory conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Septic shock (meeting severe sepsis and having persistent systolic blood pressure \<90mmHg despite adequate fluid resuscitation). Exclusion Criteria: * Unilateral or bilateral vagotomy * History of myocardial infarction or stroke in the last 1 year * Recurrent vasovagal syncope * Sick sinus syndrome without pacemaker * Bifascicular heart block * 2nd or 3rd-degree heart block * Hypotension due to autonomic dysfunction * Pregnant women * Prisoners and patients with suicidal ideation
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Houssein Youness, MD — University of Oklahoma
- Study coordinator: Houssein Youness, MD
- Email: Houssein-Youness@ouhsc.edu
- Phone: 405-271-6173
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.