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

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ClinicalTrials.gov Identifier: NCT02643459
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Martin Schultz, 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?

Condition or disease Intervention/treatment Phase
Triage Risk Stratification With Biomarker Behavioral: suPAR measurement Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Introduction of Soluble Urokinase Plasminogen Activating Receptor in Acute Care as a Prognostic Biomarker to Strengthen Risk Stratification of Acutely Admitted Patients
Study Start Date : January 2016
Actual Primary Completion Date : April 6, 2017
Actual Study Completion Date : April 6, 2017

Arm Intervention/treatment
No Intervention: Conventional
no suPAR measurement. Standard care.
Experimental: suPAR
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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. All cause mortality [ Time Frame: 1 months after index admission mortality data will assessed ]
  2. Number of discharges from the emergency room within 24 hours [ Time Frame: 30 days ]
  3. Number of admissions to the medical ward [ Time Frame: 30 days ]
  4. Number of patients with an admission to the intensive care unit [ Time Frame: 30 days ]
  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 ]
  7. Number of readmissions [ Time Frame: 30 and 90 days ]
    Patients will be followed using central registers. All new admissions within 91 days of the same patient is defined as readmissions.

  8. All cause mortality and secondary outcomes in age specific groups aged 65 or older [ Time Frame: up to 12 months ]
    with regard to number of readmissions at 30 and 90 days, Length of stay during admission at 30 days, number of patients with an admission to the intensive care unit at 30 days, number of admissions to the medical ward at 30 days, number of discharges within 24 hours from the emergency department at 30 days and all cause mortality at 30-, 90- and 365 days.

  9. All cause mortality - Subgroup analysis of patients diagnosed with cardiovascular disease [ Time Frame: 10 months after inclusion period ends ]
  10. All cause mortality - Subgroup analysis of patients diagnosed with cancer [ Time Frame: 10 months after inclusion period ends ]
  11. All cause mortality - Subgroup analysis of patients diagnosed with infections [ Time Frame: 10 months after inclusion period ends ]
  12. All cause mortality - Subgroup analysis of patients diagnosed with Neurological disease [ Time Frame: 10 months after inclusion period ends ]
  13. All cause mortality - Subgroup analysis of patients diagnosed with surgical conditions [ Time Frame: 10 months after inclusion period ends ]
  14. Economical expenses [ Time Frame: 10 months after inclusion period ends ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643459


Locations
Denmark
Herlev Hospital, Department of Cardiology
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
Study Director: Kasper K Iversen, MD, DMSci Department of Cardiology, Herlev Hospital

Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Final statistical analysis plan of feb9/2017. Primary outcome can be assesed after the 6.th of April.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin Schultz, MD, P.h.D student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02643459     History of Changes
Other Study ID Numbers: HerlevH01
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Martin Schultz, Herlev Hospital:
Triage
Risk stratification
Acute care
suPAR