Normal Human Plasma Level of iNOS Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Robert Webber, Research & Diagnostic Antibodies
ClinicalTrials.gov Identifier:
NCT01605695
First received: May 16, 2012
Last updated: November 23, 2013
Last verified: November 2013

May 16, 2012
November 23, 2013
May 2012
May 2013   (final data collection date for primary outcome measure)
Determination of the normal healthy human reference range for plasma iNOS [ Time Frame: At time of blood donation ] [ Designated as safety issue: No ]
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. .
Same as current
Complete list of historical versions of study NCT01605695 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Normal Human Plasma Level of iNOS Study
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

heparinized plasma samples

Probability Sample

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.

Normal Human Plasma Level of iNOS
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Cannot be a prisoner
Both
18 Years to 79 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01605695
RDAbs 12-002, 1RC3GM093717-01
No
Dr. Robert Webber, Research & Diagnostic Antibodies
Research & Diagnostic Antibodies
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Robert J Webber, Ph.D. Research & Diagnostic Antibodies
Research & Diagnostic Antibodies
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP