Overview

This trial is active, not recruiting.

Conditions triage, risk stratification with biomarker
Treatment supar measurement
Sponsor Herlev Hospital
Start date January 2016
End date April 2017
Trial size 20000 participants
Trial identifier NCT02643459, HerlevH01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
no suPAR measurement. Standard care.
(Experimental)
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.
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.

Primary Outcomes

Measure
All cause mortality
time frame: 10 months after the inclusions period ends mortality data will be assessed

Secondary Outcomes

Measure
All cause mortality
time frame: 1 months after index admission mortality data will assessed
Number of discharges from the emergency room within 24 hours
time frame: 30 days
Number of admissions to the medical ward
time frame: 30 days
Number of patients with an admission to the intensive care unit
time frame: 30 days
Number of patients with new cancer diagnosis in control vs intervention groups
time frame: 10 months after inclusion period ends
Length of stay during admission.
time frame: 30 days
Number of readmissions
time frame: 30 and 90 days
All cause mortality and secondary outcomes in age specific groups aged 65 or older
time frame: up to 12 months
All cause mortality - Subgroup analysis of patients diagnosed with cardiovascular disease
time frame: 10 months after inclusion period ends
All cause mortality - Subgroup analysis of patients diagnosed with cancer
time frame: 10 months after inclusion period ends
All cause mortality - Subgroup analysis of patients diagnosed with infections
time frame: 10 months after inclusion period ends
All cause mortality - Subgroup analysis of patients diagnosed with Neurological disease
time frame: 10 months after inclusion period ends
All cause mortality - Subgroup analysis of patients diagnosed with surgical conditions
time frame: 10 months after inclusion period ends
Economical expenses
time frame: 10 months after inclusion period ends

Eligibility Criteria

Male or female participants at least 16 years old.

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.

Additional Information

Official title Introduction of Soluble Urokinase Plasminogen Activating Receptor in Acute Care as a Prognostic Biomarker to Strengthen Risk Stratification of Acutely Admitted Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Herlev Hospital.