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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04118179




Registration number
NCT04118179
Ethics application status
Date submitted
4/10/2019
Date registered
8/10/2019
Date last updated
18/10/2019

Titles & IDs
Public title
New Strategy to Predict Early Sepsis
Scientific title
Development of a New Strategy to Predict Early Sepsis
Secondary ID [1] 0 0
H17-01208
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 0 0 0 0
Poisoning
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Blood sample collection

Suspected Sepsis Group - Participants suspected of potential to develop sepsis recruited at the emergency department.

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.

Healthy Group - Healthy participants


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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Severity of illness - Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring
Timepoint [1] 0 0
24 hours
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
72 hours
Secondary outcome [2] 0 0
Mortality - 28-day survival rate after admission to hospital
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
ICU length of stay - Length of stay in the Intensive Care Unit
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Quick Sequential Organ Failure Assessment (SOFA) Score greater than 2 - Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring
Timepoint [4] 0 0
6 hours

Eligibility
Key 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
Minimum age
19 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Canada
State/province [2] 0 0
Vancouver
Country [3] 0 0
Colombia
State/province [3] 0 0
Neiva
Country [4] 0 0
Netherlands
State/province [4] 0 0
Groningen

Funding & Sponsors
Primary sponsor type
Other
Name
University of British Columbia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT04118179
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Robert E Hancock, PhD
Address 0 0
University of British Columbia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Susan Farmer, BSc
Address 0 0
Country 0 0
Phone 0 0
604-827-5663
Fax 0 0
Email 0 0
sfarmer@mail.ubc.ca
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04118179