Blockade of Vascular Potassium Channels During Human Endotoxemia

Endotoxemia Clinical Trial

Official title:

Blockade of Vascular Potassium Channels During Human Endotoxemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185003
• Other study ID #: PP02
• Secondary ID: ZONMW grant 907-
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: October 16, 2008
• Start date: January 2003
• Est. completion date: June 2005

Study information

• Verified date: April 2008
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• drug, alcohol, nicotine abuse

Study Design

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

Related Conditions & MeSH terms

• Endotoxemia

Intervention

Drug:
• endotoxin

• Potassium channel blockers: TEA, Quinin, Tolbutamide

• L-NMMA

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamics		24 hrs after LPS administration
Primary	Markers of Inflammation		24 hrs after LPS administration
Primary	Cytokines		24 hrs after LPS administration
Primary	Markers of Renal Injury		24 hrs after LPS administration
Primary	Inducible NO synthase expression		24 hrs after LPS administration
Primary	NO-metabolites		24 hrs after LPS administration
Primary	Mediators of Vascular reactivity		24 hrs after LPS administration
Primary	Sensitivity to norepinephrine		24 hrs after LPS administration