Blockade of Vascular Potassium Channels During Human Endotoxemia

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00185003
First received: September 13, 2005
Last updated: October 16, 2008
Last verified: April 2008
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • drug, alcohol, nicotine abuse
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 13, 2005
Last Updated: October 16, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014