The Effect of Vagus Nerve Stimulation on the Inflammatory Response After Lung Lobectomy

June 30, 2017 updated by: Mohamed Salama, Otto Wagner Hospital
Systemic inflammation is a potentially debilitating complication of thoracic surgeries that can result in significant physical and economic morbidity for afflicted patients. There is compelling evidence for the role of central nervous system in the regulation of systemic inflammatory responses through humoral mechanisms. Activation of afferent vagus nerve fibers by cytokines triggers anti-inflammatory responses. Direct electrical stimulation of the peripheral vagus nerve in vivo during lethal endotoxemia in rats inhibited Tumor necrosis factor (TNF) synthesis in liver preventing the development of shock. The vagal regulatory role of systemic inflammation after lung lobectomy is unknown.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • Department of Thoracic Surgery, Otto-Wagner Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lung Lobectomy or pneumonectomy
  • Adult
  • Open surgery

Exclusion Criteria:

  • Current infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control
ACTIVE_COMPARATOR: Treated
Device: Vagus nerve stimulation
transcutaneous Intermittent stimulation of the vagus nerve using neurostimulator V (Ducest®, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The postsurgical inflammatory response: the effect of vagus stimulation on proinflammatory interleukin concentrations
Time Frame: 3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day
changes of serum Interleukin (IL-6, IL-10, IL-18, IL-1) concentrations in pg/ml from baseline and over the postsurgical course up to the 4th postoperative day in both study groups. The baseline is defined as the serum concentration of the target interleukins at 24 hours prior to surgery. Afterwards the changes in the interleukins concentrations will be measured on the 1st and 4th postoperative days in both groups in order to analyze the effect of vagus stimulation on the intensity of the postsurgical inflammatory response.
3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of vagus stimulation on changes in Serum C reactive protein (CRP) concentrations
Time Frame: 3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day
changes of serum CRP concentrations in mg/L from baseline and over the postsurgical course up to the 4th postoperative day in both study groups. The baseline is defined as the serum concentration of CRP at 24 hours prior to surgery. Afterwards the changes in the interleukins concentrations will be measured on the 1st and 4th postoperative days in both groups in order to analyze the effect of vagus stimulation on the intensity of the postsurgical inflammatory response.
3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otto Wagner Hospital

Investigators

  • Study Director: Michael Mueller, MD, PhD, Otto Wagner Hospital
  • Principal Investigator: Mohamed Salama, MD, PhD, Otto Wagner Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ACTUAL)

June 5, 2016

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

June 23, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (ACTUAL)

July 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Vagus Stimulation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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