EDsuPAR: Use of suPAR Algorithm for the ED Decision Making

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04402281
• Collaborator: University of Copenhagen (Other)
• Enrollment: 1,800
• Location: 1
• Actual Duration (Months): 12.7
• Patients Per Site Per Month: 141.9

Study Details

Study Description

Brief Summary

Will the use of a clinical decision algorithm in the ED improve discharge or admission decisions.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Diagnostic Test: suPAR algoritm

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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 1800 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: Use of Algorithm for Safer and More Efficient Decision Making in the ED
• Actual Study Start Date: May 11, 2020
• Actual Primary Completion Date: Jun 1, 2021
• Actual Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
suPAR algoritm control Control arm (Meilahti hospital): Samples are collected and suPAR measured but no algorithm is implemented.	Diagnostic Test: suPAR algoritm; 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
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".	Diagnostic Test: suPAR algoritm; 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

Outcome Measures

Primary Outcome Measures

1. Discharges [30 days]

   Number of discharges from the ED within 24 hours

Secondary Outcome Measures

1. Admissions [30 days]

   Number of admissions to hospital

2. Length of stay [30 days]

   Length of stay during admission

3. Readmissions [1,7 and 30 days]

   Number of readmissions

4. Mortality [30 days]

   Number of Mortality

Other Outcome Measures

1. Economical savings [30 days]

   Amount of money

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 104 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• All patients above 18 years

• who are having blood taken for biochemical analysis when attending the ED

Exclusion Criteria:

• Acute medical patients that do not have blood drawn for routine biochemical testing.

• Pregnant

• Under 18 years old

• Terminally ill patients.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Emergency Medicine and Services, Helsinki University Hospital and Helsinki University, Helsinki, Finland	Helsinki	Helsinki Usimaa	Finland

Sponsors and Collaborators

• Helsinki University Central Hospital
• University of Copenhagen

Investigators

• Principal Investigator: Maaret Castrén, Docent, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marja Mäkinen, PhD, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT04402281
• Other Study ID Numbers: §33, HUS/141/2020 14.4.2020
• First Posted: May 26, 2020
• Last Update Posted: Feb 11, 2022
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marja Mäkinen, PhD, Helsinki University Central Hospital: ED; Critical illness; Decision making; POC test; suPAR
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of Feb 11, 2022