Clinical trial NCT04118179: New Strategy to Predict Early Sepsis
Official title: Development of a New Strategy to Predict Early Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-10-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suspected of sepsis will be recruited at the emergency department of participating institutions.

Brief summary: This is an observational prospective multicentre study on patients attending the emergency department and suspected to have sepsis. Blood markers characteristic of a Cellular Reprogramming (CR) signature and predicting severe sepsis and organ failure will be measured and validated.

Detailed description: Sepsis is a life-threatening medical condition caused by an infection and the complex and dysfunctional way by which the human body attempts to deal with it. It can affect people of all ages, causing 18-30 million cases and 5-8 million deaths annually worldwide. However, early diagnosis of sepsis is challenging due to the diversity and overlap of symptoms with other disorders and the lack of an early and accurate diagnostic method. Hancock and colleagues defined a gene expression signature characteristic of biological changes occurring during sepsis, known as cellular reprogramming (CR) and reflecting a type of immune amnesia (inability to respond to bacterial signals). This signature was shown to predict the development of sepsis and organ failure at first clinical presentation in the emergency room, by examining patient blood samples taken during an initial pilot single-center study.

This project will validate and refine the CR signature and demonstrate reproducibility, specificity, and sensitivity in a larger multi-center study to enable a new strategy to predict Sepsis.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Presenting to the Emergency Department
* Attending physician suspects possible sepsis based on at least 2 sign of Systemic inflammatory response syndrome (SIRS) criteria and suspicion of infection

Exclusion Criteria:

* Patient is terminal (death anticipated in 12 hours)
* Informed consent unobtainable if the subject survives to hospital discharge.
* Subjects who are unable to provide blood as a standard of care.
* Blood sample could not be taken within 24 hours of a physician's first contact with the patient.

Primary outcomes:
measure: Severity of illness
timeFrame: 24 hours
Secondary outcomes:
measure: Sequential Organ Failure Assessment (SOFA) Score monitoring
timeFrame: 72 hours
measure: Mortality
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
measure: Quick Sequential Organ Failure Assessment (SOFA) Score greater than 2
timeFrame: 6 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas, M.D. Anderson Cancer Center
state: Texas
city: Sydney
country: Australia
facility: Westmead Hospital
city: Vancouver
country: Canada
facility: Vancouver General Hospital
city: Neiva
country: Colombia
facility: Hospital Universitario Moncaleano Perdomo
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University of British Columbia
name: Robert E Hancock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pena OM, Hancock DG, Lyle NH, Linder A, Russell JA, Xia J, Fjell CD, Boyd JH, Hancock RE. An Endotoxin Tolerance Signature Predicts Sepsis and Organ Dysfunction at Initial Clinical Presentation. EBioMedicine. 2014 Nov 1;1(1):64-71. doi: 10.1016/j.ebiom.2014.10.003.