Normal Human Plasma Level of iNOS Study

November 23, 2013 updated by: Dr. Robert Webber, Research & Diagnostic Antibodies

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • North Las Vegas, Nevada, United States, 89032
        • Research & Diagnostic Antibodies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Reference values will be obtained from 100 plasma samples obtained from healthy normal humans collected prospectively under an IRB approved protocol and informed consent after blood donation for use in research. The 100 normal human plasma samples will be assayed using the PliNOSa test.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Cannot be a prisoner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research & Diagnostic Antibodies

Collaborators

National Institute of General Medical Sciences (NIGMS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

May 16, 2012

First Submitted That Met QC Criteria

May 21, 2012

First Posted (ESTIMATE)

May 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 23, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RDAbs 12-002
  • 1RC3GM093717-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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