Clinical trial NCT04189549: Preclinical Detection of Sepsis Early in Hospitalized Patients Following Surgery, Injury or Severe Illness
Official title: Preclinical Detection of Sepsis Early in Hospitalized Patients Following Surgery, Injury or Severe Illness (Pre-SEPSIS Trial)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: Biomarker
Sepsis
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the hospital and admitted for non-sepsis conditions who are at increased risk for developing sepsis per Sepsis-3 criteria within the hospital.

Brief summary: This clinical study is to evaluate a novel biomarker - CNA Rapid Sepsis Dx - to predict the development of sepsis in patients admitted to the hospital with non-sepsis conditions. Using circulating cell-free DNA (cfDNA) in the blood stream, it has been demonstrated to detect infection response days before clinical evidence of sepsis manifests. The hypothesis is that blood biomarkers drawn daily in the hospital will identify patients who develop sepsis within seven days of hospital presentation.

Detailed description: This is a prospective observational trial evaluating CNA Rapid Sepsis Dx -novel biomarkers (CNA Diagnostics Inc.; Calgary, Canada) based on circulating cell-free DNA (cfDNA) in the blood stream to identify patients originally admitted with non-sepsis conditions who ultimately develop sepsis according to Sepsis-3 criteria within seven days of hospital presentation. This novel technology has been demonstrated to detect host-related response to infection days before clinical evidence of sepsis manifests.

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.

Eligibility criteria: Inclusion Criteria:

1. Patient 18 years of age or older at the time of enrollment
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:

1. Prisoners or in police custody
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.

Primary outcomes:
measure: Clinical development of sepsis
timeFrame: Seven Days from hospital presentation
Secondary outcomes:
measure: SIRS sepsis
timeFrame: Seven Days from hospital presentation
measure: Hospital Length of Stay
timeFrame: Up to 12 months
measure: Intensive Care Unit Length of Stay
timeFrame: Up to 6 months
measure: Development of non-Sepsis 3 Infections
timeFrame: Seven Days from hospital presentation
measure: Body Fluid Culture Results
timeFrame: Seven Days from hospital presentation
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
city: Detroit
country: United States
facility: Harper University Hospital
state: Michigan
city: Detroit
country: United States
facility: Sinai-Grace Hospital
state: Michigan
city: New York
country: United States
facility: Northwell Health
state: New York
Study officials:
References: