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

Not Applicable

Completed

Conditions: Triage
Risk Stratification With Biomarker

Interventions: Behavioral: suPAR measurement

Registration Number: NCT02643459

Lead Sponsor: Herlev Hospital

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

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20000

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
suPAR	suPAR measurement	suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR. Since suPAR is measured on all patients regardless of disease the investigators cannot define a single intervention. A possible intervention depends on the clinical situation.

Primary Outcome Measures

Name	Time	Method
All Cause Mortality	10 months after the inclusions period ends mortality data will be assessed	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.

Secondary Outcome Measures

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