Normal Human Plasma Level of iNOS Study

NCT01605695 | Completed

• 2 other identifiers: RDAbs 12-0021RC3GM093717-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Normal Human Plasma Level of iNOS

Keywords

reference range; plasma; inducible nitric oxide synthase; iNOS; healthy adults

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Cannot be a prisoner

Sponsors & Collaborators

• Research & Diagnostic Antibodies: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Research & Diagnostic Antibodies

North Las Vegas, Nevada, 89032, United States

Location

Related Publications (1)

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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

heparinized plasma samples

Study Officials

• Robert J Webber, Ph.D.

  Research & Diagnostic Antibodies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President and Project PI

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 25, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

US (1)