Normal Human Plasma Level of iNOS Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Normal Human Plasma Level of iNOS

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Aged 18-79 years of age In generally good health Exclusion Criteria: Cannot be a prisoner

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal healthy adults<br>The concentration of iNOS will be measured in plasma samples obtained at the time of blood donation from normal healthy adult humans | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the normal healthy human reference range for plasma iNOS | 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. . | At time of blood donation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy adults, reference range, plasma, inducible nitric oxide synthase, iNOS