Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. It is the most expensive healthcare condition to treat in United States and has a mortality rate of nearly 30%. It is widely known that exaggerated inflammation and imbalance between sympathetic and parasympathetic arms of the autonomic nervous system (ANS) contribute to progression and adverse outcomes in sepsis. The role of unchecked inflammation and unregulated ANS as a potential treatment target is an important gap in our knowledge that should be explored. Cholinergic anti-inflammatory pathway (CAP) is an intricate network where the ANS senses inflammation by vagus nerve afferents and tries to regulate it by vagus nerve efferents to the reticuloendothelial system. The central hypothesis of this pilot clinical trial is that transcutaneous vagus nerve stimulation (TVNS) at tragus of the external ear can activate the CAP to suppress inflammation and improve autonomic imbalance as measured by inflammatory cytokine levels and heart rate variability (HRV) analysis. The investigators plan to randomize patients with septic shock into active and sham stimulation groups and study the effects of vagal stimulation on inflammatory cytokines, HRV and a clinical severity score of sepsis. Both groups will continue to receive the standard of care treatment for sepsis irrespective of group assignments. The investigators hypothesize that 4 hours of TVNS will suppress inflammatory markers and improve the balance between sympathetic and parasympathetic arms of ANS as measured by HRV, resulting in improved Sequential Organ Failure Assessment Score (SOFA). The preliminary data generated from this pilot study will lay the foundation for a larger clinical trial.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Septic shock (meeting severe sepsis and having persistent systolic blood pressure \<90mmHg despite adequate fluid resuscitation).

Locations
United States
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Contact Information
Primary
Houssein Youness, MD
Houssein-Youness@ouhsc.edu
405-271-6173
Backup
Zain Ul Abideen Asad, MD
Zain-Asad@ouhsc.edu
405-271-5963
Time Frame
Start Date: 2019-10-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 34
Treatments
Experimental: Active Treatment
Patients will receive a single 4-hour session of active transcutaneous vagus nerve stimulation.
Sham_comparator: Sham Control
Patients will receive a single 4-hour session of sham transcutaneous vagus nerve stimulation.
Related Therapeutic Areas
Sponsors
Collaborators: Oklahoma City VA Medical Center
Leads: University of Oklahoma

This content was sourced from clinicaltrials.gov