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Blockade of Vascular Potassium Channels During Human Endotoxemia

Primary Purpose

Endotoxemia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
endotoxin
Potassium channel blockers: TEA, Quinin, Tolbutamide
L-NMMA
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endotoxemia focused on measuring Endotoxemia, vascular potassium channels, cytokine, norepinephrine, regional blood flow,, inflammation,, ion channels,, nitric oxide synthase,, pharmacology.

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: healthy volunteers Exclusion Criteria: drug, alcohol, nicotine abuse

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Hemodynamics
    Markers of Inflammation
    Cytokines
    Markers of Renal Injury
    Inducible NO synthase expression
    NO-metabolites
    Mediators of Vascular reactivity
    Sensitivity to norepinephrine

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    October 16, 2008
    Sponsor
    Radboud University Medical Center
    Collaborators
    ZonMw: The Netherlands Organisation for Health Research and Development
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00185003
    Brief Title
    Blockade of Vascular Potassium Channels During Human Endotoxemia
    Official Title
    Blockade of Vascular Potassium Channels During Human Endotoxemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2003 (undefined)
    Primary Completion Date
    June 2005 (Actual)
    Study Completion Date
    June 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Radboud University Medical Center
    Collaborators
    ZonMw: The Netherlands Organisation for Health Research and Development

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endotoxemia
    Keywords
    Endotoxemia, vascular potassium channels, cytokine, norepinephrine, regional blood flow,, inflammation,, ion channels,, nitric oxide synthase,, pharmacology.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    endotoxin
    Intervention Type
    Drug
    Intervention Name(s)
    Potassium channel blockers: TEA, Quinin, Tolbutamide
    Intervention Type
    Drug
    Intervention Name(s)
    L-NMMA
    Primary Outcome Measure Information:
    Title
    Hemodynamics
    Time Frame
    24 hrs after LPS administration
    Title
    Markers of Inflammation
    Time Frame
    24 hrs after LPS administration
    Title
    Cytokines
    Time Frame
    24 hrs after LPS administration
    Title
    Markers of Renal Injury
    Time Frame
    24 hrs after LPS administration
    Title
    Inducible NO synthase expression
    Time Frame
    24 hrs after LPS administration
    Title
    NO-metabolites
    Time Frame
    24 hrs after LPS administration
    Title
    Mediators of Vascular reactivity
    Time Frame
    24 hrs after LPS administration
    Title
    Sensitivity to norepinephrine
    Time Frame
    24 hrs after LPS administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy volunteers Exclusion Criteria: drug, alcohol, nicotine abuse
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter Pickkers, MD, PhD
    Organizational Affiliation
    Radboud University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16864730
    Citation
    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. doi: 10.1161/CIRCULATIONAHA.105.590232. Epub 2006 Jul 24.
    Results Reference
    result

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    Blockade of Vascular Potassium Channels During Human Endotoxemia

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