Clinical trial NCT01605695: Normal Human Plasma Level of iNOS Study
Official title: Determination of the Normal Human Plasma Level of Inducible Nitric Oxide Synthase (iNOS) Using the PliNOSa Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Human Plasma Level of iNOS
Keywords: reference range
plasma
inducible nitric oxide synthase
iNOS
healthy adults
Lead sponsor: Research & Diagnostic Antibodies
Sponsor class: INDUSTRY
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2012-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Cannot be a prisoner

Primary outcomes:
measure: Determination of the normal healthy human reference range for plasma iNOS
timeFrame: At time of blood donation
Secondary outcomes:
Other outcomes:
Locations:
city: North Las Vegas
country: United States
facility: Research & Diagnostic Antibodies
state: Nevada
Study officials:
affiliation: Research & Diagnostic Antibodies
name: Robert J Webber, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: How to Define and Determine Reference Intervals in the Clinical Laboratory - Approved Guidelines, Second Edition, C28 A2, Vol 20, No. 3.