New Strategy to Predict Early Sepsis

Active, not recruiting

• Conditions: Sepsis

• Registration Number: NCT04118179
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-08
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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

Trial Locations

Locations (5)

University of Texas, M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Westmead Hospital; 🇦🇺 Sydney, Australia

Vancouver General Hospital; 🇨🇦 Vancouver, Canada

Hospital Universitario Moncaleano Perdomo; 🇨🇴 Neiva, Colombia

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands