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Normal Human Plasma Level of iNOS Study

R

Research & Diagnostic Antibodies

Status

Completed

Conditions

Normal Human Plasma Level of iNOS

Study type

Observational

Funder types

Industry
NIH

Identifiers

NCT01605695
RDAbs 12-002
1RC3GM093717-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 79 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Cannot be a prisoner

Trial design

100 participants in 1 patient group

Normal healthy adults
Description:
The concentration of iNOS will be measured in plasma samples obtained at the time of blood donation from normal healthy adult humans

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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