Blockade of Vascular Potassium Channels During Human Endotoxemia

Verified by: Radboud University, April 2008
First Received: September 13, 2005 | Last Updated: October 16, 2008 | Phase: Phase 1 | Start Date: January 2003
Overall Status: Completed | Estimated Enrollment: 36
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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...

Brief Summary

Official Title: “Blockade of Vascular Potassium Channels During Human Endotoxemia”

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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • 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
  • 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

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 Investigator Information

Lead Investigator: Radboud University Other

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 February 12, 2012

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)

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