NCT04118179

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
5 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

5 years

First QC Date

October 4, 2019

Last Update Submit

June 2, 2023

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Severity of illness

    Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring

    24 hours

Secondary Outcomes (4)

  • Sequential Organ Failure Assessment (SOFA) Score monitoring

    72 hours

  • Mortality

    28 days

  • ICU length of stay

    28 days

  • Quick Sequential Organ Failure Assessment (SOFA) Score greater than 2

    6 hours

Study Arms (3)

Suspected Sepsis Group

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

Other: Blood sample collection

Surgical Group

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.

Other: Blood sample collection

Healthy Group

Healthy participants

Other: Blood sample collection

Interventions

Blood sample collectionOTHER

A blood sample (1 tube) will be collected for the analysis of the CR signature.

Healthy GroupSurgical GroupSuspected Sepsis Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suspected of sepsis will be recruited at the emergency department of participating institutions.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Texas, M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Westmead Hospital

Sydney, Australia

Location

Vancouver General Hospital

Vancouver, Canada

Location

Hospital Universitario Moncaleano Perdomo

Neiva, Colombia

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Related 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.

    PMID: 25685830BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

RNA samples obtained from whole blood.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Robert E Hancock, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Canada Research Chair and Professor, Department of Microbiology and Immunology

Study Record Dates

First Submitted

October 4, 2019

First Posted

October 8, 2019

Study Start

August 1, 2018

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

June 5, 2023

Record last verified: 2023-06

Locations

US(1)CO(1)AU(1)CA(1)NL(1)