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Blockade of Vascular Potassium Channels During Human Endotoxemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185003
First Posted: September 16, 2005
Last Update Posted: October 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
  Purpose
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.

Condition Intervention Phase
Endotoxemia Drug: endotoxin Drug: Potassium channel blockers: TEA, Quinin, Tolbutamide Drug: L-NMMA Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blockade of Vascular Potassium Channels During Human Endotoxemia

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome 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 ]

Enrollment: 36
Study Start Date: January 2003
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • drug, alcohol, nicotine abuse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185003


Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Peter Pickkers, MD, PhD Radboud University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00185003     History of Changes
Other Study ID Numbers: PP02
ZONMW grant 907-00-056
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: October 17, 2008
Last Verified: April 2008

Keywords provided by Radboud University:
Endotoxemia
vascular potassium channels
cytokine
norepinephrine
regional blood flow,
inflammation,
ion channels,
nitric oxide synthase,
pharmacology.

Additional relevant MeSH terms:
Endotoxemia
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Tolbutamide
Potassium Channel Blockers
Hypoglycemic Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action