EndotoxemiaPhase 1NCT00185003
Blockade of Vascular Potassium Channels During Human Endotoxemia
A Phase 1 study testing endotoxin, Potassium channel blockers: TEA, Quinin, Tolbutamide and L-NMMA in people with Endotoxemia, run by Radboud University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotoxemia
- What is being tested?
- endotoxin, Potassium channel blockers: TEA, Quinin, Tolbutamide and L-NMMA
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jun 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
Who cannot join
- drug, alcohol, nicotine abuse
About this study
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.
- Conditions
- Endotoxemia
- Being tested
- endotoxin, Potassium channel blockers: TEA, Quinin, Tolbutamide, L-NMMA
- Keywords
- Endotoxemia, vascular potassium channels, cytokine, norepinephrine, regional blood flow,, inflammation,, ion channels,, nitric oxide synthase,, pharmacology.
- Medical subject headings
- Endotoxemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotoxinDrug
Potassium channel blockers: TEA, Quinin, TolbutamideDrug
L-NMMADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamics
Measured: 24 hrs after LPS administration
Markers of Inflammation
Measured: 24 hrs after LPS administration
Cytokines
Measured: 24 hrs after LPS administration
Markers of Renal Injury
Measured: 24 hrs after LPS administration
Inducible NO synthase expression
Measured: 24 hrs after LPS administration
NO-metabolites
Measured: 24 hrs after LPS administration
Mediators of Vascular reactivity
Measured: 24 hrs after LPS administration
Sensitivity to norepinephrine
Measured: 24 hrs after LPS administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndotoxemiaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Peter Pickkers, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185003
- Sponsor's protocol ID
- PP02
- Other IDs
- ZONMW grant 907-00-056
- Status last verified
- Apr 2008
- First submitted
- 13 Sep 2005
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16864730
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blockade of Vascular Potassium Channels During Human Endotoxemia
- ClinicalTrials.gov ID
- NCT00185003
- Acronym / sponsor ID
- PP02
- Conditions
- Endotoxemia
- Keywords
- Endotoxemia, vascular potassium channels, cytokine, norepinephrine, regional blood flow,, inflammation,, ion channels,, nitric oxide synthase,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jan 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- drug, alcohol, nicotine abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endotoxin | Drug | – |
| Potassium channel blockers: TEA, Quinin, Tolbutamide | Drug | – |
| L-NMMA | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
- Results publication: PubMed 16864730Pickkers 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.
Related trials for Endotoxemia
Recruiting
Short-Chain Fatty Acids in Lypopolysaccharide-Induced Inflammation and Executive Function
Endotoxemia, Inflammation
Not yet recruiting
Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation
Septic Shock
Not yet recruitingObservational study
Intestinal Endotoxemia and Beta- Cell Dysfunction in Prediabetics
Prediabetic State (IGT), Prediabetic State
RecruitingObservational study
OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study
Sepsis, Septic Shock
Active, not recruiting
Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components
PreDiabetes, Dysbiosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Pickkers, MD, PhD principal investigator
Radboud University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing endotoxin, Potassium channel blockers: TEA, Quinin, Tolbutamide and L-NMMA in people with Endotoxemia, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamics (time frame: 24 hrs after LPS administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00185003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2008.