Critical IllnessEDsuPARNCT04402281
Use of suPAR Algorithm for the ED Decision Making
An observational study of Critical Illness, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Will the use of a clinical decision algorithm in the ED improve discharge or admission decisions. Read more about this study
- Who is it for?
- Ages 18 to 104 yearsHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- What is being tested?
- suPAR algoritm
- How many people
- 1,800 participants
- Where
- 1 siteFinland
- Study dates
- 11 May 2020to 1 Jun 2021
- How long will I take part?
- 1 Month
- 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 to 104 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients during the study period who signed the consent
Who may be able to join
- All patients above 18 years
- who are having blood taken for biochemical analysis when attending the ED
Who cannot join
- Acute medical patients that do not have blood drawn for routine biochemical testing.
- Pregnant
- Under 18 years old
- Terminally ill patients.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Emergency Medicine and Services, Helsinki University Hospital and Helsinki University, Helsinki, Finland
Helsinki, Helsinki Usimaa
About this study
Official title: Use of Algorithm for Safer and More Efficient Decision Making in the ED
Will the use of a clinical decision algorithm in the ED improve discharge or admission decisions.
Read the detailed description
Background Crowding and readmissions are common challenges in Emergency departments across Europe. The decision whether to admit or discharge the patient is challenging and is often based on clinical signs and symptoms e.g. blood pressure, pulse, respiratory rate, oxygen saturation and temperature. But some patients are unnecessarily admitted and may have been better off if sent home. Other patients may be discharged without - and one out of five patients are readmitted within a month raising the question whether the patient should have been admitted at first presentation in the ED. suPAR is a strong prognostic biomarker measured routinely in acute medical patients in some emergency department (ED) settings.suPAR is a broadly applicable biomarker of risk, and it has been developed an algorithm for simple interpretation of suPAR in clinical decisions for the study.
Objective To evaluate the use of a clinical decision algorithm in the ED with the aim of improving discharge or admission decisions.
- Conditions
- Critical Illness
- Being tested
- suPAR algoritm
- Keywords
- ED, Critical illness, Decision making, POC test, suPAR
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suPAR algoritmDiagnostic test
All medical patients attending to the ED and who will have blood drawn for routine examination will be part of the study. In patients with low suPAR (green group, suPAR below 3 ng/ml) and in patients with high suPAR (red group, suPAR > 6 ng/mL) the Intervention will be carried out
| Study group | Role | What they receive |
|---|---|---|
| suPAR algoritm control | Control arm (Meilahti hospital): Samples are collected and suPAR measured but no algorithm is implemented. Receives: Diagnostic Test: suPAR algoritm | |
| suPAR algoritm intervention | Intervention arm (Jorvi Hospital).
According the algorithm when admitting a patient with suPAR below 3 ng/ml, physician should answer the following question
"Are you sure it is the right decision to admit this patient? Please discuss this with a senior physician".
If discharging a patient with suPAR above 6 ng/ml, physician should answer the following question
"Are you sure it is the right decision to discharge this patient? Please discuss this with a senior physician". Receives: Diagnostic Test: suPAR algoritm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharges
Number of discharges from the ED within 24 hours
Measured: 30 days
Secondary outcomes (4)
Admissions
Number of admissions to hospital
Measured: 30 days
Length of stay
Length of stay during admission
Measured: 30 days
Readmissions
Number of readmissions
Measured: 1,7 and 30 days
Mortality
Number of Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start11 May 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Other
- Enrolment
- 1,800 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Marja Mäkinen, Helsinki University Central Hospital
- Investigators
- Maaret Castrén, Docent, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402281
- Sponsor's protocol ID
- §33, HUS/141/2020 14.4.2020
- Acronym
- EDsuPAR
- Status last verified
- Jun 2021
- First submitted
- 20 May 2020
- Last updated
- 11 Feb 2022
- Results posted
- 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 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Algorithm for Safer and More Efficient Decision Making in the ED
- ClinicalTrials.gov ID
- NCT04402281
- Acronym / sponsor ID
- EDsuPAR / §33, HUS/141/2020 14.4.2020
- Conditions
- Critical Illness
- Keywords
- ED, Critical illness, Decision making, POC test, suPAR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 11 May 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 26 May 2020 (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.
Will the use of a clinical decision algorithm in the ED improve discharge or admission decisions.
Detailed description
Background Crowding and readmissions are common challenges in Emergency departments across Europe. The decision whether to admit or discharge the patient is challenging and is often based on clinical signs and symptoms e.g. blood pressure, pulse, respiratory rate, oxygen saturation and temperature. But some patients are unnecessarily admitted and may have been better off if sent home. Other patients may be discharged without - and one out of five patients are readmitted within a month raising the question whether the patient should have been admitted at first presentation in the ED. suPAR is a strong prognostic biomarker measured routinely in acute medical patients in some emergency department (ED) settings.suPAR is a broadly applicable biomarker of risk, and it has been developed an algorithm for simple interpretation of suPAR in clinical decisions for the study.
Objective To evaluate the use of a clinical decision algorithm in the ED with the aim of improving discharge or admission decisions.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suPAR algoritm control | – | Diagnostic Test: suPAR algoritmControl arm (Meilahti hospital): Samples are collected and suPAR measured but no algorithm is implemented. |
| suPAR algoritm intervention | – | Diagnostic Test: suPAR algoritmIntervention arm (Jorvi Hospital). According the algorithm when admitting a patient with suPAR below 3 ng/ml, physician should answer the following question "Are you sure it is the right decision to admit this patient? Please discuss this with a senior physician". If discharging a patient with suPAR above 6 ng/ml, physician should answer the following question "Are you sure it is the right decision to discharge this patient? Please discuss this with a senior physician". |
Who may qualify
- Ages
- 18 to 104 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients during the study period who signed the consent
Key inclusion criteria (2 listed)
- All patients above 18 years
- who are having blood taken for biochemical analysis when attending the ED
Key exclusion criteria (4 listed)
- Acute medical patients that do not have blood drawn for routine biochemical testing.
- Pregnant
- Under 18 years old
- Terminally ill patients.
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 |
|---|---|---|
| suPAR algoritmAll medical patients attending to the ED and who will have blood drawn for routine examination will be part of the study. In patients with low suPAR (green group, suPAR below 3 ng/ml) and in patients with high suPAR (red group, suPAR > 6 ng/mL) the Intervention will be carried out | Diagnostic test | suPAR algoritm control, suPAR algoritm intervention |
Primary outcome
Discharges
Time frame: 30 days
Number of discharges from the ED within 24 hours
4 secondary outcomes
Admissions
Time frame: 30 days
Length of stay
Time frame: 30 days
Readmissions
Time frame: 1,7 and 30 days
Mortality
Time frame: 30 days
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 11 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Maaret Castrén, Docent principal investigator
Professor
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 Critical Illness, run by Helsinki University Central Hospital at 1 site in Finland.
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 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: finished, as of the sponsor's last update on 11 Feb 2022. 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 Finland. 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?
Discharges (time frame: 30 days). 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 11 Feb 2022.