跳至主要内容
临床试验/NCT01605695
NCT01605695已完成不适用

Determination of the Normal Human Plasma Level of Inducible Nitric Oxide Synthase (iNOS) Using the PliNOSa Test

Research & Diagnostic Antibodies1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Determination of the normal healthy human reference range for plasma iNOS

研究概览

简要总结

The discovery that inducible nitric oxide synthase (iNOS) circulates in people who are developing the sepsis pathology has provided an opportunity to develop a first-in-class diagnostic test for the onset of sepsis. This study is designed to determine the normal human plasma level of circulating iNOS as the initial reference level against which hospitalized patients at risk for the development of sepsis can be compared to ascertain if the patient is at risk for becoming septic based upon an elevated level of plasma iNOS.

详细描述

Infections in intensive care units (ICUs) and other hospital settings can be caused by different types of organisms, such as bacteria and fungi. Yearly, these infections cause at least 2 million patients in the USA to enter the early stages of the sepsis pathology (pre-sepsis) which will lead to more than 750,000 cases of sepsis that can deteriorate into life-threatening severe sepsis with organ dysfunction and septic shock with multiple organ failure and result in more than 250,000 deaths per year. At present, an accurate clinical lab test to predict the onset of the sepsis pathology does not exist. Thus, there is a large unmet clinical lab need for a test that can aid physicians in assessing the risk their hospitalized patients have for developing the sepsis pathology. A reliable test for predicting very early the onset of sepsis would be a major medical breakthrough. However, a reference level for normal healthy individuals is needed against which plasma levels can be compared for increased (or decreased) levels of iNOS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • Aged 18-79 years of age
  • In generally good health

排除标准

  • Cannot be a prisoner

结局指标

主要结局

Determination of the normal healthy human reference range for plasma iNOS

时间窗: At time of blood donation

The primary endpoint is the determination of the normal human plasma level of iNOS as the reference interval of the mean and it's 95% confidence interval. .

次要结局

未报告次要终点

研究者

发起方
Research & Diagnostic Antibodies
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Dr. Robert Webber

President and Project PI

Research & Diagnostic Antibodies

研究点 (1)

Loading locations...

相似试验