SepsisNCT04118179
New Strategy to Predict Early Sepsis
An observational study of Sepsis, run by University of British Columbia at 5 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- Blood sample collection
- How many people
- 1,000 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Aug 2018to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients suspected of sepsis will be recruited at the emergency department of participating institutions.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Development of a New Strategy to Predict Early Sepsis
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.
Read the 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
- Being tested
- Blood sample collection
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
A blood sample (1 tube) will be collected for the analysis of the CR signature.
| Study group | Role | What they receive |
|---|---|---|
| Suspected Sepsis Group | Participants suspected of potential to develop sepsis recruited at the emergency department. Receives: 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. Receives: Other: Blood sample collection | |
| Healthy Group | Healthy participants Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of illness
Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring
Measured: 24 hours
Secondary outcomes (4)
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.
Measured: 72 hours
Mortality
28-day survival rate after admission to hospital
Measured: 28 days
ICU length of stay
Length of stay in the Intensive Care Unit
Measured: 28 days
Quick Sequential Organ Failure Assessment (SOFA) Score greater than 2
Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Aug 2018
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Bob Hancock, University of British Columbia
- Investigators
- Robert E Hancock, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118179
- Sponsor's protocol ID
- H17-01208
- Status last verified
- Jun 2023
- First submitted
- 4 Oct 2019
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The RNA-Seq data will be uploaded to Geo database when the study is complete or upon publication and will be freely available to researchers.
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. doi: 10.1016/j.ebiom.2014.10.003.
PubMed 25685830
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Strategy to Predict Early Sepsis
- ClinicalTrials.gov ID
- NCT04118179
- Acronym / sponsor ID
- H17-01208
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suspected Sepsis Group | – | Other: Blood sample collectionParticipants suspected of potential to develop sepsis recruited at the emergency department. |
| Surgical Group | – | Other: Blood sample collectionParticipants 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 | – | Other: Blood sample collectionHealthy participants |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of sepsis will be recruited at the emergency department of participating institutions.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionA blood sample (1 tube) will be collected for the analysis of the CR signature. | Other | Healthy Group, Surgical Group, Suspected Sepsis Group |
Primary outcome
Severity of illness
Time frame: 24 hours
Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring
4 secondary outcomes
Sequential Organ Failure Assessment (SOFA) Score monitoring
Time frame: 72 hours
Mortality
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Quick Sequential Organ Failure Assessment (SOFA) Score greater than 2
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Background: PubMed 25685830Pena 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.
- Individual participant dataSharing planned: Undecided. The RNA-Seq data will be uploaded to Geo database when the study is complete or upon publication and will be freely available to researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert E Hancock, PhD principal investigator
University of British Columbia
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by University of British Columbia at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, Canada, Colombia, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of illness (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.