Status:
COMPLETED
Anti-inflammatory Effects of GTS-21 After LPS
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
CoMentis
Conditions:
Endotoxemia
Sepsis
Eligibility:
MALE
18-35 years
Phase:
NA
Brief Summary
Rationale: The vagus nerve exerts an anti-inflammatory effect in in vitro and animal experiments. This 'vagal anti-inflammatory pathway' is mediated by the nicotinergic α7nACh receptor that can be sel...
Detailed Description
INTRODUCTION AND RATIONALE: The innate immune response is the first line of defense against invading pathogens(1). This tightly regulated system consists of a wide variety of chemokines, cytokines, ce...
Eligibility Criteria
Inclusion
- Age ≥ 18 and ≤ 35 yrs
- Male
- Healthy
Exclusion
- Use of any medication
- Smoking
- History, signs or symptoms of cardiovascular disease
- (Family) history of cerebrovascular disease
- Previous vagal collapse
- 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 test
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00783068
Start Date
August 1 2008
End Date
August 1 2010
Last Update
November 5 2010
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6525 GA