Plasma Inducible Nitric Oxide Synthase (iNOS) Assay and Sepsis Study (PliNOSa® Test)

This study has suspended participant recruitment.
(NIH funding ended prior to full enrollment in the clinical study)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Robert Webber, Research & Diagnostic Antibodies
ClinicalTrials.gov Identifier:
NCT01371929
First received: June 8, 2011
Last updated: November 23, 2013
Last verified: November 2013
  Purpose

The primary objective is to demonstrate that the plasma inducible nitric oxide synthase (iNOS) assay (PliNOSa® test) has an acceptable relative risk ratio for predicting the onset of sepsis within 72 hours of testing when performed on the first day a patient is admitted or transferred to the intensive care unit (ICU) and is considered to be at risk of becoming septic. The PliNOSa® test measures inducible nitric oxide synthase (iNOS) in plasma and uses a pre-determined iNOS cut-off value to identify patients at risk for the onset of the sepsis pathology.


Condition
Sepsis
Severe Sepsis
Septic Shock

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of the PliNOSa® Test as an Aid in the Risk Assessment for the Onset of Sepsis

Resource links provided by NLM:


Further study details as provided by Research & Diagnostic Antibodies:

Primary Outcome Measures:
  • Evaluation of the PliNOSa test for a Positive Percent Agreement greater than 75% or a Negative Percent Agreement greater than 75% for predicting in ICU patients the onset of sepsis diagnosed within 72 hours of a plasma sample collected on study day 1. [ Time Frame: First 72 hours after entry into the ICU ] [ Designated as safety issue: No ]
    A successful result (rejection of the null hypothesis) will be achieved if the Positive Percent Agreement is greater than 75% or the Negative Percent Agreement is greater than 75%.


Biospecimen Retention:   Samples Without DNA

heparinized plasma samples


Estimated Enrollment: 300
Study Start Date: February 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICU patients who become septic
Patients considered to be at risk of becoming septic based upon his/her clinical presentation during admittance or transfer to an ICU will be tested for the presence of plasma iNOS using our PliNOSa test on the day of ICU entry and their sepsis status will be followed for three days to determine if they develop sepsis, severe sepsis, or septic shock. Approximately, 50% of the enrolled patients are expected to develop sepsis, severe sepsis, or septic shock.
ICU patients who do not become septic
Patients considered to be at risk of becoming septic based upon his/her clinical presentation during admittance or transfer to an ICU will be tested for the presence of plasma iNOS using our PliNOSa test on the day of ICU entry and their sepsis status will be followed for three days to determine if they develop sepsis, severe sepsis, or septic shock. Approximately, 50% of the enrolled patients are expected NOT to develop sepsis, severe sepsis, or septic shock.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population will consist of 290 consecutively enrolled critically ill ICU patients who are considered to be at risk of becoming septic based upon their clinical presentation due to trauma, or a surgical procedure, or threatened or actual respiratory failure, or hemodynamic instability; and recruited from three clinical sites. The first 40 study subjects will comprise the pilot cohort and the remaining 250 study subjects will comprise the pivotal cohort.

Criteria

Inclusion Criteria:

  • Male or female
  • 18 years of age or older
  • May be designated Do Not Attempt to Resuscitate / Do Not Intubate (DNAR / DNI) if they are committed to FULL CARE
  • Study subject or their legal representative must have read, understood and provided written informed consent after the clinical study has been fully explained and their questions answered
  • Subject must be admitted to or transferred to an Intensive Care Unit (ICU) and expected to require ICU-level of Care >24 hours for any of the following reasons:

    • Following a surgical procedure
    • Following a traumatic injury
    • For threatened or actual respiratory failure
    • For hemodynamic instability
  • Subject is considered to be at risk of developing sepsis during the next 72 hours based upon his/her clinical presentation
  • Must have an in-dwelling line from which blood can be drawn.

Exclusion Criteria:

  • Cannot be already septic, severely septic or in septic shock as defined by a recent positive culture (< 48 hrs) plus 2 or more of the signs and symptoms of sepsis listed in Table 1, "Diagnostic Criteria for Sepsis" in Levy MM, et al (2003) Crit Care Med, 31#4:1250-1256.
  • Cannot be moribund (not expected to survive 48 hours)
  • Cannot be expected to be discharged from the ICU in under 3 days
  • Cannot be pregnant
  • Cannot be a prisoner
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371929

Sponsors and Collaborators
Research & Diagnostic Antibodies
Investigators
Principal Investigator: Robert J Webber, Ph.D. Research & Diagnostic Antibodies
  More Information

Publications:
Responsible Party: Dr. Robert Webber, President, Research & Diagnostic Antibodies
ClinicalTrials.gov Identifier: NCT01371929     History of Changes
Other Study ID Numbers: RDAbs 11-001, 1RC3GM093717-01
Study First Received: June 8, 2011
Last Updated: November 23, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014