Skip to main content
OpenTrials
Completed

NCT Number: NCT03204968

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammatory Response

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Thoracic Surgery, Otto-Wagner Hospital

Vienna, 1140, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lung Lobectomy or pneumonectomy
  • Adult
  • Open surgery

Exclusion criteria

  • Current infection

Treatment and study plan

vagus nerve stimulation

Device

transcutaneous Intermittent stimulation of the vagus nerve using neurostimulator V (Ducest®, Germany)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Otto Wagner Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 2, 2017
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.