Preclinical Detection of Sepsis Early in Hospitalized Patients Following Surgery, Injury or Severe Illness
NCT ID: NCT04189549
Last Updated: 2019-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2019-12-09
2021-04-30
Brief Summary
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Detailed Description
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The primary objective of this study is to assess the performance of the novel diagnostic assay, CNA Rapid Sepsis Dx, based on the biomarkers, drawn daily from the day of hospital presentation, to identify patients who ultimately develop sepsis according to Sepsis-3-definition within seven days of hospital presentation.
The secondary objective is to correlate the CNA Rapid Sepsis Dx with clinically relevant outcomes such as infections that otherwise do not meet Sepsis-3 criteria, intensive care unit (ICU) length of stay, hospital length of stay, fluid culture results, and hospital mortality.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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CNA Rapid Sepsis Dx
Novel biomarker based on circulating cell-free DNA (cfDNA) in the human blood stream
Eligibility Criteria
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Inclusion Criteria
2. Presence of any of the following high-risk features:
* Victims of trauma with either an Injury Severity Score of ≥ 15 or a Glasgow Coma Score of ≤ 8\[2\] OR
* Any patient undergoing high-risk surgical procedures including any emergency surgery and high risk elective surgery procedures involving the thorax, esophagus, stomach, small bowel, large bowel \[3, 4\] OR
* Any patient being admitted to any ICU setting for any reason with no current evidence or suspicion of active infection (by primary team).\[5, 6\]
3. Able to collect sample within 24 hours of presentation to the hospital.
Exclusion Criteria
2. Pregnancy
3. Pre-existing infection for which patient is being treated with antibiotics as an outpatient.
4. Plan for ongoing antibiotic therapy by treating team (up to three doses antibiotics for peri-procedure prophylaxis is allowable).
5. Moribund, unlikely to survive the duration of active enrollment
6. Comfort care measures in place or ordered at time of screening OR indication from treating team that active medical care will not be pursued due to patient's condition or patient's/family's wishes.
7. Palliative care or hospice consult at time of screening.
18 Years
ALL
No
Sponsors
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Robert Ehrman
OTHER
Responsible Party
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Robert Ehrman
Assistant Professor of Emergency Medicine
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Harper University Hospital
Detroit, Michigan, United States
Sinai-Grace Hospital
Detroit, Michigan, United States
Northwell Health
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Alyssa Kirkman
Role: primary
Samuel Ceckowski
Role: primary
Samuel Ceckowski
Role: primary
Thomas Mazzocco
Role: primary
Ramona Ramdeo
Role: primary
Other Identifiers
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2019R110
Identifier Type: -
Identifier Source: org_study_id