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Normal Human Plasma Level of iNOS Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605695
First Posted: May 25, 2012
Last Update Posted: November 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Dr. Robert Webber, Research & Diagnostic Antibodies
  Purpose
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.

Condition
Normal Human Plasma Level of iNOS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of the Normal Human Plasma Level of Inducible Nitric Oxide Synthase (iNOS) Using the PliNOSa Test

Further study details as provided by Dr. Robert Webber, Research & Diagnostic Antibodies:

Primary Outcome Measures:
  • 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. .


Biospecimen Retention:   Samples Without DNA
heparinized plasma samples

Enrollment: 100
Study Start Date: May 2012
Study Completion Date: September 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Cannot be a prisoner
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605695


Locations
United States, Nevada
Research & Diagnostic Antibodies
North Las Vegas, Nevada, United States, 89032
Sponsors and Collaborators
Research & Diagnostic Antibodies
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Robert J Webber, Ph.D. Research & Diagnostic Antibodies
  More Information

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

Responsible Party: Dr. Robert Webber, President and Project PI, Research & Diagnostic Antibodies
ClinicalTrials.gov Identifier: NCT01605695     History of Changes
Other Study ID Numbers: RDAbs 12-002
1RC3GM093717-01 ( U.S. NIH Grant/Contract )
First Submitted: May 16, 2012
First Posted: May 25, 2012
Last Update Posted: November 26, 2013
Last Verified: November 2013

Keywords provided by Dr. Robert Webber, Research & Diagnostic Antibodies:
reference range
plasma
inducible nitric oxide synthase
iNOS
healthy adults

Additional relevant MeSH terms:
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents