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

Not Applicable

Completed

• Conditions: Inflammatory Response
• Interventions: Device: Vagus nerve stimulation

• Registration Number: NCT03204968
• Lead Sponsor: Otto Wagner Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-01
• Primary Completion: 2016-06-05
• Status Verified: 2017-06
• Study Completion: 2017-06-01
• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-29
• Last Update Submitted: 2017-06-30
• Study First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Lung Lobectomy or pneumonectomy
• Adult
• Open surgery

Exclusion Criteria

• Current infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treated	Vagus nerve stimulation	-

Primary Outcome Measures

Name	Time	Method
The postsurgical inflammatory response: the effect of vagus stimulation on proinflammatory interleukin concentrations	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 Outcome Measures

Name	Time	Method
The effect of vagus stimulation on changes in Serum C reactive protein (CRP) concentrations	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.

Trial Locations

Locations (1)

Department of Thoracic Surgery, Otto-Wagner Hospital; 🇦🇹 Vienna, Austria