Plasma Inducible Nitric Oxide Synthase (iNOS) Assay and Sepsis Study (PliNOSa® Test)
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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 |
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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 |
- Testing the PliNOSa test for an acceptable relative risk ratio for predicting the onset of sepsis within 72 hours of a plasma sample being collected on the first day critically ill patients enter the ICU [ Time Frame: First 96 hours after entry into the ICU ] [ Designated as safety issue: No ]A successful result will be achieved if the relative risk ratio is greater than 2.5 and the lower bound of the 95% confidence interval is greater than 2.0.
Biospecimen Retention: Samples Without DNA
heparinized plasma samples
| Estimated Enrollment: | 300 |
| Groups/Cohorts |
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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.
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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.
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The study population will consist of 290 consecutively enrolled critically ill ICU patients who are considered to be 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 four clinical sites. The first 40 study subjects (10 at each enrollment site) will comprise the "training set" cohort and the remaining 250 study subjects will comprise the "clinical validation" cohort.
Inclusion Criteria:
- Male or female
- Aged 18-79 years of age
- 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| Contact: Robert J Webber, Ph.D. | 702-638-7800 | RJWebber@RDAbs.com |
| Contact: Douglas S Webber, Ph.D. | 702-638-7800 | DSWebber@RDAbs.com |
| 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: | May 15, 2012 |
| 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:
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Sepsis Toxemia Shock Shock, Septic |
Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013