Using nerve stimulation to manage inflammation in septic shock
Official title: Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
Run by University of Oklahoma · NCT03992378 · Data updated 2026-11-12
This study is testing if a new ear stimulation technique can help reduce inflammation and improve recovery in patients with septic shock.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Status | Recruiting |
| Started | October 10, 2019 |
| Main results expected | June 2027 |
| Study ends | December 2027 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT03992378 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with septic shock who have persistent low blood pressure despite receiving adequate fluid resuscitation.
✕Probably not a fit
Patients with a history of certain heart conditions, autonomic dysfunction, or those who are pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
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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.
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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.