New Strategy to Predict Early Sepsis

University of British Columbia

Status: Active, not recruiting

Conditions: Sepsis

Treatments: Other: Blood sample collection

Study type: Observational

Funder types: Other

Identifiers

NCT04118179

H17-01208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,000 participants in 3 patient groups

Suspected Sepsis Group

Description:

Participants suspected of potential to develop sepsis recruited at the emergency department.

Treatment:

Other: Blood sample collection

Surgical Group

Description:

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.

Treatment:

Other: Blood sample collection

Healthy Group

Description:

Healthy participants

Treatment:

Other: Blood sample collection