New Strategy to Predict Early Sepsis

Active, not recruiting

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Suspected Sepsis Group	Blood sample collection	Participants suspected of potential to develop sepsis recruited at the emergency department.
Surgical Group	Blood sample collection	Participants undergoing non-emergency scheduled surgery, including ear/nose and throat cases, orthopaedic surgery of the major joints including hip, knee, ankle, shoulder, and wrist.
Healthy Group	Blood sample collection	Healthy participants

Primary Outcome Measures

Name	Time	Method
Severity of illness	24 hours	Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring

Secondary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA) Score monitoring	72 hours	The organs scored are respiratory, cardiovascular, neurologic, hematologic, renal, and liver. Each organ is scored as 0 (best) to 4 (worse) and the total score is the sum of each component.
Mortality	28 days	28-day survival rate after admission to hospital
ICU length of stay	28 days	Length of stay in the Intensive Care Unit
Quick Sequential Organ Failure Assessment (SOFA) Score greater than 2	6 hours	Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring

Locations (5): Westmead Hospital
🇦🇺
Sydney, Australia
Vancouver General Hospital
🇨🇦
Vancouver, Canada
Hospital Universitario Moncaleano Perdomo
🇨🇴
Neiva, Colombia
University Medical Center Groningen
🇳🇱
Groningen, Netherlands
University of Texas, M.D. Anderson Cancer Center
🇺🇸
Houston, Texas, United States

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