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Normal Human Plasma Level of iNOS Study

NCT ID: NCT01605695

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-09-30

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.

Conditions

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Normal Human Plasma Level of iNOS

Keywords

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reference range plasma inducible nitric oxide synthase iNOS healthy adults

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal healthy adults

The concentration of iNOS will be measured in plasma samples obtained at the time of blood donation from normal healthy adult humans

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

Research & Diagnostic Antibodies

INDUSTRY

Sponsor Role lead

Responsible Party

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Dr. Robert Webber

President and Project PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert J Webber, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Research & Diagnostic Antibodies

Locations

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Research & Diagnostic Antibodies

North Las Vegas, Nevada, United States

Site Status

Countries

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United States

References

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How to Define and Determine Reference Intervals in the Clinical Laboratory - Approved Guidelines, Second Edition, C28 A2, Vol 20, No. 3.

Reference Type BACKGROUND

Other Identifiers

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1RC3GM093717-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RDAbs 12-002

Identifier Type: -

Identifier Source: org_study_id