Inflammatory ResponseNCT03204968
The Effect of Vagus Nerve Stimulation on the Inflammatory Response After Lung Lobectomy
A study testing Vagus nerve stimulation in people with Inflammatory Response, run by Otto Wagner Hospital at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- Vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2015to 1 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lung Lobectomy or pneumonectomy
- Adult
- Open surgery
Who cannot join
- Current infection
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Thoracic Surgery, Otto-Wagner Hospital
Vienna, 1140
About this study
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.
- Conditions
- Inflammatory Response
- Being tested
- Vagus nerve stimulation
- Keywords
- vagus nerve, Lung lobectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve stimulationDevice
transcutaneous Intermittent stimulation of the vagus nerve using neurostimulator V (Ducest®, Germany)
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| Treated | Active comparator | Not described Receives: Device: Vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Dec 2015
- Primary completion5 Jun 2016
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto Wagner Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salama, Otto Wagner Hospital
- Investigators
- Michael Mueller, MD, PhD, Study director, Otto Wagner HospitalMohamed Salama, MD, PhD, Principal investigator, Otto Wagner Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204968
- Sponsor's protocol ID
- Vagus Stimulation
- Status last verified
- Jun 2017
- First submitted
- 23 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32358638
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vagus Nerve Stimulation on the Inflammatory Response After Lung Lobectomy
- ClinicalTrials.gov ID
- NCT03204968
- Acronym / sponsor ID
- Vagus Stimulation
- Conditions
- Inflammatory Response
- Keywords
- vagus nerve, Lung lobectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Otto Wagner HospitalUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 5 Jun 2016 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| Treated | Active comparator | Device: Vagus nerve stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Lung Lobectomy or pneumonectomy
- Adult
- Open surgery
Key exclusion criteria (1 listed)
- Current infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus nerve stimulationtranscutaneous Intermittent stimulation of the vagus nerve using neurostimulator V (Ducest®, Germany) | Device | Treated |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Derived from this study: PubMed 32358638Salama 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Mueller, MD, PhD study director
Otto Wagner Hospital
Mohamed Salama, MD, PhD principal investigator
Otto Wagner Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus nerve stimulation in people with Inflammatory Response, run by Otto Wagner Hospital at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03204968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.