Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT02675868
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Age ≥18 and ≤35 yrs
* Male
* Healthy
Exclusion Criteria:
* Use of any medication
* Smoking
* Previous spontaneous vagal collapse
* History of atrial or ventricular arrhythmia
* (Family) history of myocardial infarction or stroke under the age of 65 years
* Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block
* Hypertension (defined as RR systolic \> 160 or RR diastolic \> 90)
* Hypotension (defined as RR systolic \< 100 or RR diastolic \< 50)
* Renal impairment (defined as plasma creatinin \>120 μmol/l)
* Liver enzyme abnormalities
* Medical history of any disease associated with immune deficiency
* CRP \> 20 mg/L, WBC \> 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxin administration
* Participation in a drug trial or donation of blood 3 months prior to the LPS challenge
* Use of recreational drugs within 7 days prior to experiment day
* Recent hospital admission or surgery with general anaesthesia (\<3 months)
* Known anaphylaxis or hypersensitivity to the study drugs or their excipients
* Recent anaesthesia with halogenated agents
* Known cardiovascular disease (coronary artery disease)
* Known chronic nephritis
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT02675868
Study Brief:
Protocol Section:
NCT02675868