Normal Human Plasma Level of iNOS Study

Completed

• Conditions: Normal Human Plasma Level of iNOS

• Registration Number: NCT01605695
• Lead Sponsor: Research & Diagnostic Antibodies

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-16
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-25
• Primary Completion: 2013-05
• Study Completion: 2013-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-23
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Cannot be a prisoner

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the normal healthy human reference range for plasma iNOS	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. .

Trial Locations

Locations (1)

Research & Diagnostic Antibodies; 🇺🇸 North Las Vegas, Nevada, United States