Use of suPAR Algorithm for the ED Decision Making

NCT ID: NCT04402281

Last Updated: 2022-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-11

Study Completion Date

2021-06-01

Brief Summary

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

Detailed Description

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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

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Critical Illness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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suPAR algoritm control

Control arm (Meilahti hospital): Samples are collected and suPAR measured but no algorithm is implemented.

suPAR algoritm

Intervention Type DIAGNOSTIC_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

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".

suPAR algoritm

Intervention Type DIAGNOSTIC_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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

104 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marja Mäkinen

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maaret Castrén, Docent

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Department of Emergency Medicine and Services, Helsinki University Hospital and Helsinki University, Helsinki, Finland

Helsinki, Helsinki Usimaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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§33, HUS/141/2020 14.4.2020

Identifier Type: -

Identifier Source: org_study_id

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