NCT03204968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

June 23, 2017

Last Update Submit

June 30, 2017

Conditions

Inflammatory Response

Keywords

vagus nerveLung lobectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

control

NO INTERVENTION

Treated

ACTIVE COMPARATOR
Device: Vagus nerve stimulation

Interventions

Vagus nerve stimulationDEVICE

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

Treated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lung Lobectomy or pneumonectomy
  • Adult
  • Open surgery

You may not qualify if:

  • Current infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic Surgery, Otto-Wagner Hospital

Vienna, 1140, Austria

Location

Related Publications (1)

  • Salama M, Akan A, Mueller MR. Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve Attenuates the Acute Inflammatory Response After Lung Lobectomy. World J Surg. 2020 Sep;44(9):3167-3174. doi: 10.1007/s00268-020-05543-w.

    PMID: 32358638DERIVED

Related Links

MeSH Terms

Interventions

Vagus Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Michael Mueller, MD, PhD

    Otto Wagner Hospital

    STUDY DIRECTOR

  • Mohamed Salama, MD, PhD

    Otto Wagner Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 23, 2017

First Posted

July 2, 2017

Study Start

December 1, 2015

Primary Completion

June 5, 2016

Study Completion

June 1, 2017

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

AU(1)