Severe SepsisNCT03960203
Effect of a Sepsis Prediction Algorithm on Clinical Outcomes
A study testing InSight in people with Severe Sepsis, run by Dascena.
Trial summary
In this clinical outcomes analysis, the effect of a machine learning algorithm for severe sepsis prediction on in-hospital mortality, hospital length of stay, and 30-day readmission was evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- InSight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75,147 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients over the age of 18 presenting to the emergency department or admitted to an inpatient unit at the participating facilities were automatically included for clinical outcomes analysis
Who cannot join
- Patients under the age of 18
About this study
Official title: Effect of a Sepsis Prediction Algorithm on Patient Mortality, Length of Stay, and Readmission
In this clinical outcomes analysis, the effect of a machine learning algorithm for severe sepsis prediction on in-hospital mortality, hospital length of stay, and 30-day readmission was evaluated.
Read the detailed description
Materials and Methods: Clinical outcomes evaluation performed on a multiyear, multicenter clinical data set of real-world data containing 75,147 patient encounters from nine hospitals. Mortality, hospital length of stay, and 30-day readmission analysis performed for 17,758 adult patients who met two or more Systemic Inflammatory Response Syndrome (SIRS) criteria at any point during their stay.
- Conditions
- Severe Sepsis
- Being tested
- InSight
- Keywords
- Dascena, Patient mortality, Length of stay, Readmissions, Algorithm, Diagnostic, Clinical outcomes
- Medical subject headings
- Sepsis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InSightDiagnostic test
Clinical decision support (CDS) system for severe sepsis detection and prediction
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Experimental | The comparator arm will involve patients monitored by InSight. Receives: Diagnostic Test: InSight |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Rate of in-hospital mortality based on SIRS criteria
Measured: 1 year
Secondary outcomes (2)
Hospital length of stay
Duration of hospital length of stay in days based on SIRS criteria
Measured: 1 year
30-day readmissions
Rate of patient readmissions within 30 days
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study startJan 2017
- Primary completionJun 2018
- Study completionJun 2018
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 Severe SepsisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Masking
- None (open label)
- Enrolment
- 75,147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dascena
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ritankar Das, MSc, Principal investigator, Dascena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960203
- Sponsor's protocol ID
- 05172019
- Status last verified
- May 2019
- First submitted
- 17 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burdick H, Pino E, Gabel-Comeau D, McCoy A, Gu C, Roberts J, Le S, Slote J, Pellegrini E, Green-Saxena A, Hoffman J, Das R. Effect of a sepsis prediction algorithm on patient mortality, length of stay and readmission: a prospective multicentre clinical outcomes evaluation of real-world patient data from US hospitals. BMJ Health Care Inform. 2020 Apr;27(1):e100109. doi: 10.1136/bmjhci-2019-100109.
PubMed 32354696
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Sepsis Prediction Algorithm on Patient Mortality, Length of Stay, and Readmission
- ClinicalTrials.gov ID
- NCT03960203
- Acronym / sponsor ID
- 05172019
- Conditions
- Severe Sepsis
- Keywords
- Dascena, Patient mortality, Length of stay, Readmissions, Algorithm, Diagnostic, Clinical outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75,147 participants (actual)
- Lead sponsor
- DascenaIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 22 May 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.
In this clinical outcomes analysis, the effect of a machine learning algorithm for severe sepsis prediction on in-hospital mortality, hospital length of stay, and 30-day readmission was evaluated.
Detailed description
Materials and Methods: Clinical outcomes evaluation performed on a multiyear, multicenter clinical data set of real-world data containing 75,147 patient encounters from nine hospitals. Mortality, hospital length of stay, and 30-day readmission analysis performed for 17,758 adult patients who met two or more Systemic Inflammatory Response Syndrome (SIRS) criteria at any point during their stay.
Study design
- Primary purpose
- Diagnosis
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparator | Experimental | Diagnostic Test: InSightThe comparator arm will involve patients monitored by InSight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over the age of 18 presenting to the emergency department or admitted to an inpatient unit at the participating facilities were automatically included for clinical outcomes analysis
Key exclusion criteria (1 listed)
- Patients under the age of 18
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 |
|---|---|---|
| InSightClinical decision support (CDS) system for severe sepsis detection and prediction | Diagnostic test | Comparator |
Primary outcome
In-hospital mortality
Time frame: 1 year
Rate of in-hospital mortality based on SIRS criteria
2 secondary outcomes
Hospital length of stay
Time frame: 1 year
30-day readmissions
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Derived from this study: PubMed 32354696Burdick H, Pino E, Gabel-Comeau D, McCoy A, Gu C, Roberts J, Le S, Slote J, Pellegrini E, Green-Saxena A, Hoffman J, Das R. Effect of a sepsis prediction algorithm on patient mortality, length of stay and readmission: a prospective multicentre clinical outcomes evaluation of real-world patient data from US hospitals. BMJ Health Care Inform. 2020 Apr;27(1):e100109. doi: 10.1136/bmjhci-2019-100109.
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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.
Ritankar Das, MSc principal investigator
Dascena
Questions about this trial
What is this clinical trial studying?
A study testing InSight in people with Severe Sepsis, run by Dascena.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In-hospital mortality (time frame: 1 year). 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 NCT03960203, 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 24 May 2019.