Transcutaneous vagus nerve stimulation for prophylaxis of systemic inflammatory response syndrome (SIRS) and treatment of SIRS-associated ileus (NeuroSIRS)
- Conditions
- Healthy subjects
- Registration Number
- DRKS00016892
- Lead Sponsor
- Medizinischen FakultätUniversitätsklinikum Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting withdrawn before recruiting started
- Sex
- Male
- Target Recruitment
- 30
Signed consent form
- Age > 18 years and < 45 years
- male gender
- Caucasian origin.
- smokers
- known predisposition to constipation or diarrhea
- surgery or trauma associated with increased blood loss or transfusion of erythrocyte concentrates
- Blood donation in the last four weeks
- taking an immunosuppressive or immunomodulatory medication in the last six months
- Regular medication intake
- Anamnestically known or indications for cardiovascular pre-existing conditions
- vasovagal or orthostatic syncope in the last 12 months
- resting pulse < 50/min or > 100/min
- Blood pressure systolic > 150 mmHg or < 100 mmHg
- Electrocardiographically proven or anamnestically known cardiac arrhythmias (except 1st-degree AV block)
- severe forms of atopy (e.g. allergic rhinoconjunctivitis, atopic dermatitis) or known allergies to LPS
- COPD or bronchial asthma in the anamnesis
- Pacemaker, internal defibrillator or other permanent electrical implants
- known epilepsy
- impaired renal function with a creatinine above the norm
- alkaline phosphatase and aspartate aminotransferase increased threefold above the norm
- known immunosuppression (e.g. by known HIV infection, taking immunosuppressive drugs or congenital immunodeficiencies)
- Leukocytosis > 12 G/l or clinically detectable infection
- feverish infection in the last two weeks before screening
- swallowing disorders
- Aspiration event in the anamnesis
- Stomach Bezoar in the anamnesis
- suspected or known strictures, fistulas or physiological/mechanical GI obstruction
- any abdominal surgery in the last three months
- abdominal surgical operations in anamnesis (exception: appendectomy, cholecystectomy or minimally invasive procedures)
- chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- Sigmadiverticulitis in the last three months
- diabetes mellitus
- Diseases of the adrenal medulla
- Subjects after splenectomy
- Inability to understand the significance and consequences of this clinical trial.
- Participation in another clinical trial involving the taking of an investigational product or the use of a medical device up to 30 days prior to participation in that clinical trial
- known abuse of medication, drugs or alcohol
- Lack of suitability of the volunteer to participate in the study in accordance with the investigator's instructions
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the mean value of the points reached in the Kox score over the measurement period (with and without tVNS).
- Secondary Outcome Measures
Name Time Method