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Blockade of Vascular Potassium Channels During Human Endotoxemia

This study has been completed.
Study NCT00185003.   Last updated on October 16, 2008.   Information provided by Radboud University

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Descriptive Information Fields
Brief Title  Blockade of Vascular Potassium Channels During Human Endotoxemia
Official Title  Blockade of Vascular Potassium Channels During Human Endotoxemia
Brief Summary

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.

Detailed Description
Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary Outcome Measure  Hemodynamics [ Time Frame: 24 hrs after LPS administration ]
Markers of Inflammation [ Time Frame: 24 hrs after LPS administration ]
Cytokines [ Time Frame: 24 hrs after LPS administration ]
Markers of Renal Injury [ Time Frame: 24 hrs after LPS administration ]
Inducible NO synthase expression [ Time Frame: 24 hrs after LPS administration ]
NO-metabolites [ Time Frame: 24 hrs after LPS administration ]
Mediators of Vascular reactivity [ Time Frame: 24 hrs after LPS administration ]
Sensitivity to norepinephrine [ Time Frame: 24 hrs after LPS administration ]
Secondary Outcome Measure 
Condition  Endotoxemia
Intervention  Drug: endotoxin
Drug: Potassium channel blockers: TEA, Quinin, Tolbutamide
Drug: L-NMMA
MEDLINE PMIDs 16864730
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  36
Start Date  January 2003
Completion Date June 2005
Eligibility Criteria 

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • drug, alcohol, nicotine abuse
Gender Both
Ages 18 Years to 35 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00185003
Organization ID PP02
Secondary IDs †† ZONMW grant 907-00-056
Study Sponsor  Radboud University
Collaborators †† ZonMw: The Netherlands Organisation for Health Research and Development
Investigators 
Principal Investigator:     Peter Pickkers, MD, PhD     Radboud University    
Information Provided By Radboud University
Verification Date April 2008
First Received Date  September 13, 2005
Last Updated Date October 16, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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