Ignite Creation Date:
2024-05-06 @ 1:21 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03992378
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2019-06-05
Brief Title:
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NERINASEPSIS
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None