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临床试验/NCT00184990
NCT00184990已完成1 期

Effect of Selective iNOS Inhibition During Human Endotoxemia

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2005年1月最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
7
试验地点
2
主要终点
Hemodynamics

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers

排除标准

  • tendency towards fainting
  • alcohol abuse
  • nicotine abuse
  • drugs abuse

结局指标

主要结局

Hemodynamics

时间窗: 24 hrs after LPS administration

Markers of Inflammation

时间窗: 24 hrs after LPS administration

Cytokines

时间窗: 24 hrs after LPS administration

Markers of Renal Injury

时间窗: 24 hrs after LPS administration

Inducible NO synthase expression

时间窗: 24 hrs after LPS administration

NO-metabolites

时间窗: 24 hrs after LPS administration

Mediators of Vascular reactivity

时间窗: 24 hrs after LPS administration

Sensitivity to norepinephrine

时间窗: 24 hrs after LPS administration

Endothelial-dependent vasorelaxation

时间窗: 24 hrs after LPS administration

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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