The effects of concentration/meditation on the innate immune response during human endotoxemia
- Conditions
- blood poisoning/sepsis1000381610004018
- Registration Number
- NL-OMON36635
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
One male volunteer who masters the concentration/meditation technique.
Use of any medication.
Smoking.
Bleeding disorder.
Previous spontaneous vagal collapse.
History, signs or symptoms of cardiovascular disease.
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 or positive hepatitis serology.
Positive HIV serology or any other obvious disease associated with immune deficiency.
Febrile illness in the week before the LPS challenge.
Participation in another drug trial or donation of blood 3 months prior to the planned LPS
challenge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the concentration of circulating TNF-a following<br /><br>LPS administration.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters include temperature, hemodynamic parameters (blood<br /><br>pressure and heart rate), illness score, catecholamines, heart rate<br /><br>variability, muscle sympathetic nerve activity, electroencephalography, other<br /><br>circulating cytokines (IL6, IL10 and IL1RA) and subclinical renal injury.</p><br>