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Completed

NCT Number: NCT02643459

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

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

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Key information

Conditions

Triage Risk Stratification With Biomarker

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev Hospital, Department of Cardiology

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

suPAR measurement

Behavioral

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

  1. All Cause Mortality

    Time frame: 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 outcomes

  1. All Cause Mortality

    Time frame: 1 months after index admission mortality data will assessed

    Mortality within 30 days

  2. Number of Discharges From the Emergency Room Within 24 Hours

    Time frame: 24 hours

    How many patients are discharged directly from the ED

  3. Number of Admissions to the Medical Ward

    Time frame: 30 days

    Number of Participants with Admissions to the Medical War

  4. Number of Patients With an Admission to the Intensive Care Unit

    Time frame: 30 days

    Number of Participants with transfer to the ICU

  5. Number of Patients With New Cancer Diagnosis in Control vs Intervention Groups

    Time frame: 10 months after inclusion period ends

  6. Length of Stay During Admission.

    Time frame: 30 days

    Length of stay in days during the admission

  7. Number of Readmissions

    Time frame: 90 days

    Patients will be followed using central registers. All new admissions within 90 days of the same patient is defined as readmissions.

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

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

Acronym: suPAR

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 31, 2015
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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