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Neuromodulation

Vagus Nerve Stimulation for Sepsis (NERINASEPSIS Trial)

Q: Are there any vacancies available to join this clinical trial?

<p>According to the clinicaltrials.gov website, this experiment is currently seeking participants. The trial was first announced on November 1st 2020 and has been updated most recently on October 15th 2020.</p>

Q: How large is the recruitment pool for this medical research project?

<p>Affirmative. According to the clinicaltrials.gov database, this medical study is actively seeking participants with its first posting on November 1st 2020 and most recent update on October 15th 2020. 34 individuals are being sought for enrolment at one location.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 hours and baseline to 24 hours post stimulation

Awards & highlights

NERINASEPSIS Trial 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.Check my eligibility

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.See study design

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.

NERINASEPSIS Trial 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.

NERINASEPSIS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 hours and baseline to 24 hours post stimulation

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Inflammatory Cytokine Tumor Necrosis Factor Alpha

Secondary outcome measures

Change in Heart Rate Variability

Change in Sequential Organ Failure Assessment Score

NERINASEPSIS 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

97,579 Total Patients Enrolled

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

Media Library

Low Level Transcutaneous Vagus Nerve Stimulation (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT03992378 — N/A

Septic Shock Research Study Groups: Active Treatment, Sham Control

Septic Shock 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available to join this clinical trial?

"According to the clinicaltrials.gov website, this experiment is currently seeking participants. The trial was first announced on November 1st 2020 and has been updated most recently on October 15th 2020."

Answered by AI

How large is the recruitment pool for this medical research project?

"Affirmative. According to the clinicaltrials.gov database, this medical study is actively seeking participants with its first posting on November 1st 2020 and most recent update on October 15th 2020. 34 individuals are being sought for enrolment at one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis

2019. "Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03992378.

All > Sepsis