Effect of Selective iNOS Inhibition During Human Endotoxemia
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Sepsis or endotoxemia is manifested by hypotension, resistance to vasopressors, myocardial depression,and altered organ blood flow distribution. The mechanisms underlying the cardiovascular dysfunction during sepsis are complex; however, they are partially mediated by an uncontrolled production of NO by inducible NO synthase (iNOS).Control subjects received 2 ng/kg E. coli endotoxin, whereas the active intervention group received endotoxin in the presence of selective iNOS-inhibitor aminoguanidine. Hemodynamics, vascular responses to norepinephrine, acetylcholine and sodium nitroprusside, as well as circulating cytokines and other mediators of inflammation were measured. We tested the hypothesis that inhibition of NO-synthesis prevented the LPS-mediated insensitivity to noradrenalin and endothelial-dependent vasorelaxation. Furthermore, we tested whether NO participates in occurrence of the endotoxin tolerance in humans by using the iNOS inhibitor aminoguanidine on healthy volunteers with endotoxemia. At 0; 2 and 4 hours after the LPS challenge whole blood was stimulated with five TLR agonists in vitro and pro- and anti-inflammatory cytokines were measured.
| Condition | Intervention | Phase |
|---|---|---|
|
Endotoxemia |
Drug: Aminoguanidine Drug: endotoxin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effect of Selective iNOS Inhibition During Human Endotoxemia |
- 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 ]
- Endothelial-dependent vasorelaxation [ Time Frame: 24 hrs after LPS administration ]
| Enrollment: | 7 |
| Study Start Date: | January 2005 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 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 |
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- tendency towards fainting
- alcohol abuse
- nicotine abuse
- drugs abuse
Contacts and Locations| Netherlands | |
| Radboud University Nijmegen Medical Centre | |
| Nijmegen, Gelderland, Netherlands, 6500HB | |
| Principal Investigator: | Peter Pickkers, PhD | Radboud University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00184990 History of Changes |
| Other Study ID Numbers: | PP01 |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 14, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
Endotoxemia Aminoguanidine |
Additional relevant MeSH terms:
|
Endotoxemia Bacteremia Sepsis Infection Toxemia Systemic Inflammatory Response Syndrome |
Inflammation Pathologic Processes Pimagedine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013