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OpenTrials
Completed

NCT Number: NCT01605695

Normal Human Plasma Level of iNOS Study

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.

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Key information

Conditions

Normal Human Plasma Level of iNOS

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research & Diagnostic Antibodies

North Las Vegas, Nevada, 89032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Cannot be a prisoner

Treatment and study plan

Primary outcomes

  1. 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. .

Sponsors and collaborators

Lead sponsor

Research & Diagnostic Antibodies

Industry

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 25, 2012
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.