NCT04402281

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 11, 2022

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

May 20, 2020

Last Update Submit

January 28, 2022

Conditions

Keywords

EDCritical illnessDecision makingPOC testsuPAR

Outcome Measures

Primary Outcomes (1)

  • Discharges

    Number of discharges from the ED within 24 hours

    30 days

Secondary Outcomes (4)

  • Admissions

    30 days

  • Length of stay

    30 days

  • Readmissions

    1,7 and 30 days

  • Mortality

    30 days

Other Outcomes (1)

  • Economical savings

    30 days

Study Arms (2)

suPAR algoritm control

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

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".

Diagnostic Test: suPAR algoritm

Interventions

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

suPAR algoritm controlsuPAR algoritm intervention

Eligibility Criteria

Age18 Years - 104 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients during the study period who signed the consent

You may qualify if:

  • All patients above 18 years
  • who are having blood taken for biochemical analysis when attending the ED

You may not qualify if:

  • Acute medical patients that do not have blood drawn for routine biochemical testing.
  • Pregnant
  • Under 18 years old
  • Terminally ill patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Helsinki, Helsinki Usimaa, Finland

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maaret Castrén, Docent

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 26, 2020

Study Start

May 11, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 11, 2022

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations