SepsisGENIUSNCT05095220
Integration of NAVOY® Sepsis in an Electronic Health Record System
An observational study of Sepsis, run by AlgoDx at 1 site in Sweden.
Trial summary
The study aims to evaluate the performance of NAVOY® Sepsis in predicting the sepsis risk in adult ICU patients. Data collection is performed via automatic retrieval from the electronic health record system to AlgoDx proprietary cloud service where it is analysed in a simulated environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- 27 May 2022to 8 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU patients admitted to the ICU during the enrolment period.
Who may be able to join
- The subject is admitted to the ICU during the enrolment period.
- The subject is 18 years of age or older at the time of admission to the ICU.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integration and Evaluation of a Machine Learning Algorithm for Sepsis Prediction in an Electronic Health Record System - a Prospective Observational Study
The study aims to evaluate the performance of NAVOY® Sepsis in predicting the sepsis risk in adult ICU patients. Data collection is performed via automatic retrieval from the electronic health record system to AlgoDx proprietary cloud service where it is analysed in a simulated environment.
- Conditions
- Sepsis
- Keywords
- sepsis, ICU, prediction, decision support, machine learning, intensive care
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAVOY® Sepsis prediction performance
NAVOY® Sepsis prediction output within the simulated environment will be monitored and compared to the observed fulfilment of Sepsis-3 diagnosis criteria and sepsis specific management.
Measured: 6 months
Secondary outcomes (4)
Integration validation
A technical checklist will be used in order to validate the integration between NAVOY® Sepsis and the electronic health record system.
Measured: 6 months
NAVOY® Sepsis prediction results
The NAVOY® Sepsis predictions results indicate if the subject is at risk of developing sepsis within the coming hours. The results are not made available to ICU staff.
Measured: 6 months
Fulfilment of Sepsis-3 criteria
The dimensions of the Sepsis-3 diagnosis criteria that the subjects meet during their ICU stay.
Measured: 6 months
Sepsis specific management
Actions taken at the ICU specifically as part of sepsis detection, prevention, or treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start27 May 2022
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlgoDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Arlbrandt, MD, Principal investigator, Southern General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095220
- Sponsor's protocol ID
- SEP-SE-03
- Acronym
- GENIUS
- Status last verified
- May 2023
- First submitted
- 30 Sep 2021
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration and Evaluation of a Machine Learning Algorithm for Sepsis Prediction in an Electronic Health Record System - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05095220
- Acronym / sponsor ID
- GENIUS / SEP-SE-03
- Conditions
- Sepsis
- Keywords
- sepsis, ICU, prediction, decision support, machine learning, intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AlgoDxIndustry (pharma, biotech, devices)
- Study start
- 27 May 2022 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 27 Oct 2021 (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.
The study aims to evaluate the performance of NAVOY® Sepsis in predicting the sepsis risk in adult ICU patients. Data collection is performed via automatic retrieval from the electronic health record system to AlgoDx proprietary cloud service where it is analysed in a simulated environment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients admitted to the ICU during the enrolment period.
Key inclusion criteria (2 listed)
- The subject is admitted to the ICU during the enrolment period.
- The subject is 18 years of age or older at the time of admission to the ICU.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NAVOY® Sepsis prediction performance
Time frame: 6 months
NAVOY® Sepsis prediction output within the simulated environment will be monitored and compared to the observed fulfilment of Sepsis-3 diagnosis criteria and sepsis specific management.
4 secondary outcomes
Integration validation
Time frame: 6 months
NAVOY® Sepsis prediction results
Time frame: 6 months
Fulfilment of Sepsis-3 criteria
Time frame: 6 months
Sepsis specific management
Time frame: 6 months
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 22 May 2023.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Martin Arlbrandt, MD principal investigator
Southern General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by AlgoDx at 1 site in Sweden.
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 2 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 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
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?
NAVOY® Sepsis prediction performance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2023.