Risk Stratification in Acute Care: The Meaning of suPAR Measurement in Triage

Triage Clinical Trial

— suPAR  

Official title:

Introduction of Soluble Urokinase Plasminogen Activating Receptor in Acute Care as a Prognostic Biomarker to Strengthen Risk Stratification of Acutely Admitted Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02643459
• Other study ID #: HerlevH01
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 6, 2017

Study information

• Verified date: February 2021
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Will clinical outcome for patients be improved if triage in Acute wards and Emergency rooms is supplemented with a prognostic biomarker?

Description:

In a health care system where the general population is growing, more patients are living with chronic conditions and the hospitals are reducing beds and length of stay, it is crucial to perform safe and fast risk stratification of patients presenting in the Emergency departments. Risk stratification is currently performed with a combination of measurement of the vital signs and assessment of the primary complaint. The aim of the current study is to assess whether the supplement of biomarkers can improve the risk stratification in regard to mortality, readmissions and improve overall patient flow in the Emergency departments. Soluble urokinase plasminogen activating receptor (suPAR) is the soluble form of urokinase-type plasminogen activator receptor (uPAR). uPAR is present on various immunological active cells, as well as endothelia and smooth muscle cells. It is believed that suPAR mirrors the inflammatory response in patients. Previous studies have shown a strong association with mortality and severity of disease in a broad variety of conditions (infection, hepatic-, renal-, cardiac- and lung disease) as well as a possible marker of disease development in the general population. These abilities indicate that suPAR although unspecific would be ideal to identify patients at high- and at low-risk. The aim is to target interventions and limited clinical focus where it is most beneficial. In unselected patients suPAR is one of the strongest prognostic biomarker available to date.

It is not known whether information on prognosis in the Emergency department can be used to prevent death, serious complications or reduce admissions and readmissions.

The purpose of the current study is to examine if introduction of the biomarker suPAR and education of doctors in the meaning of suPAR levels and association to disease, can reduce mortality, admissions and readmission in patients referred to the emergency rooms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20000
• Est. completion date: April 6, 2017
• Est. primary completion date: April 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting acutely to the Acute ward/Emergency department and have blood samples done which include both Hemoglobin, C reactive protein and Creatinine within 6 hours of registration within the study period. The study is carried out in 2 Hospitals in the Capital of Denmark.

Exclusion Criteria:

• Patients presenting in Pediatric, Gynecological or Obstetric units. Patients not being examined with blood samples.

Related Conditions & MeSH terms

• Risk Stratification With Biomarker
• Triage

Intervention

Behavioral:
• suPAR measurement
The biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge.

Locations

Country	Name	City	State
Denmark	Herlev Hospital, Department of Cardiology	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Cause Mortality	Time frame starts at the beginning of the index admission, defined as first admission in the study period. Patients will be followed using central registers.	10 months after the inclusions period ends mortality data will be assessed
Secondary	All Cause Mortality	Mortality within 30 days	1 months after index admission mortality data will assessed
Secondary	Number of Discharges From the Emergency Room Within 24 Hours	How many patients are discharged directly from the ED	24 hours
Secondary	Number of Admissions to the Medical Ward	Number of Participants with Admissions to the Medical War	30 days
Secondary	Number of Patients With an Admission to the Intensive Care Unit	Number of Participants with transfer to the ICU	30 days
Secondary	Number of Patients With New Cancer Diagnosis in Control vs Intervention Groups		10 months after inclusion period ends
Secondary	Length of Stay During Admission.	Length of stay in days during the admission	30 days
Secondary	Number of Readmissions	Patients will be followed using central registers. All new admissions within 90 days of the same patient is defined as readmissions.	90 days