New Strategy to Predict Early Sepsis

Sepsis Clinical Trial

Official title:

Development of a New Strategy to Predict Early Sepsis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04118179
• Other study ID #: H17-01208
• Status: Active, not recruiting
• Start date: August 1, 2018
• Est. completion date: July 31, 2023

Study information

• Verified date: June 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• Blood sample collection
A blood sample (1 tube) will be collected for the analysis of the CR signature.

Locations

Country	Name	City	State
Australia	Westmead Hospital	Sydney
Canada	Vancouver General Hospital	Vancouver
Colombia	Hospital Universitario Moncaleano Perdomo	Neiva
Netherlands	University Medical Center Groningen	Groningen
United States	University of Texas, M.D. Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Colombia,  Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of illness	Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring	24 hours
Secondary	Sequential Organ Failure Assessment (SOFA) Score monitoring	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.	72 hours
Secondary	Mortality	28-day survival rate after admission to hospital	28 days
Secondary	ICU length of stay	Length of stay in the Intensive Care Unit	28 days
Secondary	Quick Sequential Organ Failure Assessment (SOFA) Score greater than 2	Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring	6 hours