Blockade of Vascular Potassium Channels During Human Endotoxemia

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00185003
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development (Other)
• Enrollment: 36
• Duration (Months): 29

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endotoxemia	Drug: endotoxin; Drug: Potassium channel blockers: TEA, Quinin, Tolbutamide; Drug: L-NMMA	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Blockade of Vascular Potassium Channels During Human Endotoxemia
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Jun 1, 2005
• Actual Study Completion Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

1. Hemodynamics [24 hrs after LPS administration]

2. Markers of Inflammation [24 hrs after LPS administration]

3. Cytokines [24 hrs after LPS administration]

4. Markers of Renal Injury [24 hrs after LPS administration]

5. Inducible NO synthase expression [24 hrs after LPS administration]

6. NO-metabolites [24 hrs after LPS administration]

7. Mediators of Vascular reactivity [24 hrs after LPS administration]

8. Sensitivity to norepinephrine [24 hrs after LPS administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• drug, alcohol, nicotine abuse

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Radboud University Medical Center
• ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

• Principal Investigator: Peter Pickkers, MD, PhD, Radboud University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00185003
• Other Study ID Numbers: PP02; ZONMW grant 907-00-056
• First Posted: Sep 16, 2005
• Last Update Posted: Oct 17, 2008
• Last Verified: Apr 1, 2008

• Keywords provided by , ,: Endotoxemia; vascular potassium channels; cytokine; norepinephrine; regional blood flow,; inflammation,; ion channels,; nitric oxide synthase,; pharmacology.
• Additional relevant MeSH terms: Endotoxemia; Tolbutamide; Potassium Channel Blockers

Study Results

No Results Posted as of Oct 17, 2008