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Neuromodulation

Vagus Nerve Stimulation for Sepsis (NERINASEPSIS Trial)

N/A
Recruiting
Led By Zain Ul Abideen Asad, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Septic shock (meeting severe sepsis and having persistent systolic blood pressure <90mmHg despite adequate fluid resuscitation).
Be older than 18 years old
Must not have
Hypotension due to autonomic dysfunction
Recurrent vasovagal syncope
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 hours and baseline to 24 hours post stimulation

Summary

This trial is testing whether or not stimulating the vagus nerve can help treat sepsis, a life-threatening organ dysfunction caused by the body's response to infection.

Who is the study for?
This trial is for patients with septic shock who have low blood pressure even after fluid treatment. It's not for those with certain heart conditions, recent heart attack or stroke, autonomic dysfunction, vagotomy (vagus nerve cut), pregnant women, prisoners, suicidal individuals, or people prone to fainting.
What is being tested?
The study tests if stimulating the ear's vagus nerve can reduce inflammation and balance the nervous system in sepsis patients. Participants are randomly placed into two groups: one receives real stimulation while both get standard care; effects on inflammation and organ failure scores are compared.
What are the potential side effects?
Since this trial involves non-invasive nerve stimulation rather than medication, side effects may be minimal but could include discomfort at the stimulation site or temporary changes in heart rate or blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have septic shock with low blood pressure despite treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have low blood pressure due to a nerve system issue.
Select...
I frequently faint due to sudden drops in my heart rate and blood pressure.
Select...
I have had surgery to cut the nerves to my stomach.
Select...
I have sick sinus syndrome and do not have a pacemaker.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 hours and baseline to 24 hours post stimulation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 hours and baseline to 24 hours post stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Inflammatory Cytokine Tumor Necrosis Factor Alpha
Secondary study objectives
Change in Heart Rate Variability
Change in Sequential Organ Failure Assessment Score

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TreatmentExperimental Treatment1 Intervention
Patients will receive a single 4-hour session of active transcutaneous vagus nerve stimulation.
Group II: Sham ControlPlacebo Group1 Intervention
Patients will receive a single 4-hour session of sham transcutaneous vagus nerve stimulation.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
474 Previous Clinical Trials
93,660 Total Patients Enrolled
2 Trials studying Sepsis
1,000 Patients Enrolled for Sepsis
Oklahoma City VA Medical CenterFED
1 Previous Clinical Trials
698 Total Patients Enrolled
Zain Ul Abideen Asad, MDPrincipal InvestigatorUniversity of Oklahoma
1 Previous Clinical Trials
28 Total Patients Enrolled
Houssein Youness, MDPrincipal InvestigatorUniversity of Oklahoma
4 Previous Clinical Trials
125 Total Patients Enrolled

Media Library

Low Level Transcutaneous Vagus Nerve Stimulation (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT03992378 — N/A
Sepsis Research Study Groups: Sham Control, Active Treatment
Sepsis Clinical Trial 2023: Low Level Transcutaneous Vagus Nerve Stimulation Highlights & Side Effects. Trial Name: NCT03992378 — N/A
Low Level Transcutaneous Vagus Nerve Stimulation (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03992378 — N/A
~3 spots leftby Jun 2025
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