Preclinical Detection of Sepsis Early in Hospitalized Patients Following Surgery, Injury or Severe Illness

NCT04189549 | Unknown DMC FDA Device

• 1 other identifier: 2019R110
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Sepsis

Keywords

Biomarker; Sepsis

Outcome Measures

Primary Outcomes (1)

• Clinical development of sepsis

  Sepsis determined according to Sepsis-3 definition

  Seven Days from hospital presentation

Secondary Outcomes (5)

• SIRS sepsis

  Seven Days from hospital presentation

• Hospital Length of Stay

  Up to 12 months

• Intensive Care Unit Length of Stay

  Up to 6 months

• Development of non-Sepsis 3 Infections

  Seven Days from hospital presentation

• Body Fluid Culture Results

  Seven Days from hospital presentation

Interventions

CNA Rapid Sepsis Dx DIAGNOSTIC_TEST

Novel biomarker based on circulating cell-free DNA (cfDNA) in the human blood stream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient 18 years of age or older at the time of enrollment
• 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).\[5, 6\]
• Able to collect sample within 24 hours of presentation to the hospital.

You may not qualify if:

• Prisoners or in police custody
• Pregnancy
• Pre-existing infection for which patient is being treated with antibiotics as an outpatient.
• Plan for ongoing antibiotic therapy by treating team (up to three doses antibiotics for peri-procedure prophylaxis is allowable).
• Moribund, unlikely to survive the duration of active enrollment
• 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.
• Palliative care or hospice consult at time of screening.

Sponsors & Collaborators

• Robert Ehrman: lead

Study Sites (5)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

Harper University Hospital

Detroit, Michigan, 48201, United States

Location

Sinai-Grace Hospital

Detroit, Michigan, 48235, United States

Location

Northwell Health

New York, New York, 11042, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Patrick Medado

CONTACT

3135777500; pmedado@wayne.edu

Linda Gojcevic

CONTACT

3135777500; linda.gojcevic@wayne.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 6, 2019
• Study Start: December 9, 2019
• Primary Completion: November 1, 2020
• Study Completion: April 30, 2021
• Last Updated: December 6, 2019

Record last verified: 2019-12

Locations

US (5)