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NCT03992378 · ClinicalTrials.gov registry record · NA
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
A NA study of Septic Shock, sponsored by University of Oklahoma.
- Recruiting
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT03992378 is a NA study of Septic Shock that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 34 participants, below the 5,058-participant average among 24 other Septic Shock trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03992378, a NA study of Septic Shock, is actively recruiting participants, sponsored by University of Oklahoma.
- RECRUITING
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Low Level Transcutaneous Vagus Nerve Stimulation
Study Locations (1)
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-10-10 |
| Est. Completion | 2025-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03992378
The ClinicalTrials.gov registry entry for NCT03992378 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,058-participant average among 24 other Septic Shock trials with a reported enrollment target (99% lower). The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Septic Shock appearing as the primary indexed condition, and to 1 intervention - of which Low Level Transcutaneous Vagus Nerve Stimulation is the first listed.
NCT03992378 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.
Frequently Asked Questions
What is clinical trial NCT03992378 about?
NCT03992378 is a clinical study titled "Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis". 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 par...
What is the current status of trial NCT03992378?
This trial is currently recruiting. It is a NA study. The enrollment target is 34 participants. The study started on 2019-10-10. Estimated completion is 2025-12.
What conditions does trial NCT03992378 study?
This clinical trial studies the following conditions: Septic Shock.
What interventions are being tested in trial NCT03992378?
The interventions under investigation include: Low Level Transcutaneous Vagus Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT03992378?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03992378 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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