NCT04118179

New Strategy to Predict Early Sepsis

Development of a New Strategy to Predict Early Sepsis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
OTHER	Blood sample collection	A blood sample (1 tube) will be collected for the analysis of the CR signature.

Timeline

• Start date: 2018-08-01
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2019-10-08
• Last updated: 2023-06-05

Locations

5 sites across 5 countries: United States, Australia, Canada, Colombia, Netherlands