DRKS00016892招募中1 期
Transcutaneous vagus nerve stimulation for prophylaxis of systemic inflammatory response syndrome (SIRS) and treatment of SIRS-associated ileus (NeuroSIRS) - NeuroSIRS
Medizinischen FakultätUniversitätsklinikum Bonn0 个研究点目标入组 30 人开始时间: 2020年7月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •Signed consent form
- •- Age > 18 years and < 45 years
- •- male gender
- •- Caucasian origin.
排除标准
- •- 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
研究者
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