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

Inflammatory Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204968
• Other study ID #: Vagus Stimulation
• Status: Completed
• Phase: N/A
• First received: June 23, 2017
• Last updated: June 30, 2017
• Start date: December 1, 2015
• Est. completion date: June 1, 2017

Study information

• Verified date: June 2017
• Source: Otto Wagner Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 1, 2017
• Est. primary completion date: June 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Lung Lobectomy or pneumonectomy

• Adult

• Open surgery

Exclusion Criteria:

• Current infection

Related Conditions & MeSH terms

• Inflammatory Response

Intervention

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

Locations

Country	Name	City	State
Austria	Department of Thoracic Surgery, Otto-Wagner Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Otto Wagner Hospital

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The postsurgical inflammatory response: the effect of vagus stimulation on proinflammatory interleukin concentrations	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	The effect of vagus stimulation on changes in Serum C reactive protein (CRP) concentrations	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

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