Background: Activation of NO-synthase and vascular potassium (K) channels may play a role in the sepsis-induced attenuated sensitivity to norepinephrine. We examined whether various K channel blockers and NO-synthase inhibition could restore norepinephrine sensitivity during experimental human endotoxemia...
Date First Received: September 13, 2005
Last Updated: October 16, 2008
Verified by: Radboud University, April 2008
Clinical Trial Phase: Phase 1 | Start Date: January 2003
Overall Status: Completed
Estimated Enrollment: 36
Brief Summary
Official Title: “Blockade of Vascular Potassium Channels During Human Endotoxemia”
Condition Keyword(s):
Background: Activation of NO-synthase and vascular potassium (K) channels may play a role in the sepsis-induced attenuated sensitivity to norepinephrine. We examined whether various K channel blockers and NO-synthase inhibition could restore norepinephrine sensitivity during experimental human endotoxemia.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Study Primary Completion Date: June 2005
Intervention(s) in this Clinical Trial
- Drug: endotoxin
- Drug: Potassium channel blockers: TEA, Quinin, Tolbutamide
- Drug: L-NMMA
Outcome Measures for this Clinical Trial
Primary Measures
- Hemodynamics
- Time Frame: 24 hrs after LPS administration
- Time Frame: 24 hrs after LPS administration
- Markers of Inflammation
- Time Frame: 24 hrs after LPS administration
- Time Frame: 24 hrs after LPS administration
- Cytokines
- Time Frame: 24 hrs after LPS administration
- Time Frame: 24 hrs after LPS administration
- Markers of Renal Injury
- Time Frame: 24 hrs after LPS administration
- Time Frame: 24 hrs after LPS administration
- Inducible NO synthase expression
- Time Frame: 24 hrs after LPS administration
- Time Frame: 24 hrs after LPS administration
- NO-metabolites
- Time Frame: 24 hrs after LPS administration
- Time Frame: 24 hrs after LPS administration
- Mediators of Vascular reactivity
- Time Frame: 24 hrs after LPS administration
- Time Frame: 24 hrs after LPS administration
- Sensitivity to norepinephrine
- Time Frame: 24 hrs after LPS administration
- Time Frame: 24 hrs after LPS administration
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
- drug, alcohol, nicotine abuse
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 35 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Radboud University
Overall Clinical Trial Officials and Contacts
Peter Pickkers, MD, PhD Principal Investigator Radboud University
Related Publications
Citations Reporting Results
Pickkers P, Dorresteijn MJ, Bouw MP, van der Hoeven JG, Smits P. In vivo evidence for nitric oxide-mediated calcium-activated potassium-channel activation during human endotoxemia. Circulation. 2006 Aug 1;114(5):414-21. Epub 2006 Jul 24.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00185003
Study ID Number: PP02
ClinicalTrials.gov Identifier: NCT00185003
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Clinical Trials Authorship and Review
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