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

• Sponsor: Herlev Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02643459
• Collaborator: (none)
• Enrollment: 20,000
• Location: 1
• Arms: 2
• Duration (Months): 15.1
• Patients Per Site Per Month: 1320.5

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jan 1, 2016
• Actual Primary Completion Date: Apr 6, 2017
• Actual Study Completion Date: Apr 6, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. All Cause Mortality [1 months after index admission mortality data will assessed]

   Mortality within 30 days

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

   How many patients are discharged directly from the ED

3. Number of Admissions to the Medical Ward [30 days]

   Number of Participants with Admissions to the Medical War

4. Number of Patients With an Admission to the Intensive Care Unit [30 days]

   Number of Participants with transfer to the ICU

5. Number of Patients With New Cancer Diagnosis in Control vs Intervention Groups [10 months after inclusion period ends]

6. Length of Stay During Admission. [30 days]

   Length of stay in days during the admission

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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 Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 4, 2018

More Information

Publications

None provided.

• Responsible Party: Martin Schultz, MD, P.h.D student, Herlev Hospital
• ClinicalTrials.gov Identifier: NCT02643459
• Other Study ID Numbers: HerlevH01
• First Posted: Dec 31, 2015
• Last Update Posted: Mar 9, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Martin Schultz, MD, P.h.D student, Herlev Hospital: Triage; Risk stratification; Acute care; suPAR

Study Results

Participant Flow

Arm/Group Title	Conventional	suPAR
Arm/Group Description	no suPAR measurement. Standard care.	suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
Period Title: Overall Study
STARTED	7901	8900
COMPLETED	7901	8900
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Conventional	suPAR	Total
Arm/Group Description	no suPAR measurement. Standard care.	suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.	Total of all reporting groups
Overall Participants	7901	8900	16801
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.9 (20.7)	60.4 (20.8)	60.6 (20.7)
Sex: Female, Male (Count of Participants)
Female	4175 52.8%	4689 52.7%	8864 52.8%
Male	3726 47.2%	4211 47.3%	7937 47.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	7901 100%	8900 100%	16801 100%
Region of Enrollment (participants) [Number]
Denmark	7901 100%	8900 100%	16801 100%

Outcome Measures

1. Primary Outcome

Title	All Cause Mortality
Description	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.
Time Frame	10 months after the inclusions period ends mortality data will be assessed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description	no suPAR measurement. Standard care.	suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
Measure Participants	7901	8900
Count of Participants [Participants]	1126 14.3%	1241 13.9%

2. Secondary Outcome

Title	All Cause Mortality
Description	Mortality within 30 days
Time Frame	1 months after index admission mortality data will assessed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description	no suPAR measurement. Standard care.	suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
Measure Participants	7901	8900
Count of Participants [Participants]	319 4%	359 4%

3. Secondary Outcome

Title	Number of Discharges From the Emergency Room Within 24 Hours
Description	How many patients are discharged directly from the ED
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description	no suPAR measurement. Standard care.	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.
Measure Participants	7901	8900
Count of Participants [Participants]	3934 49.8%	4352 48.9%

4. Secondary Outcome

Title	Number of Admissions to the Medical Ward
Description	Number of Participants with Admissions to the Medical War
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description	no suPAR measurement. Standard care.	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.
Measure Participants	7901	8900
Count of Participants [Participants]	3500 44.3%	3738 42%

5. Secondary Outcome

Title	Number of Patients With an Admission to the Intensive Care Unit
Description	Number of Participants with transfer to the ICU
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description	no suPAR measurement. Standard care.	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.
Measure Participants	7901	8900
Count of Participants [Participants]	1027 13%	1157 13%

6. Secondary Outcome

Title	Number of Patients With New Cancer Diagnosis in Control vs Intervention Groups
Time Frame	10 months after inclusion period ends

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description	no suPAR measurement. Standard care.	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.
Measure Participants	7901	8900
Count of Participants [Participants]	687 8.7%	917 10.3%

7. Secondary Outcome

Title	Length of Stay During Admission.
Description	Length of stay in days during the admission
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description	no suPAR measurement. Standard care.	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.
Measure Participants	7901	8900
Mean (Standard Error) [Days]	4.53 (8.7)	4.39 (8.27)

8. Secondary Outcome

Title	Number of Readmissions
Description	Patients will be followed using central registers. All new admissions within 90 days of the same patient is defined as readmissions.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional	suPAR
Arm/Group Description	no suPAR measurement. Standard care.	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.
Measure Participants	7901	8900
Count of Participants [Participants]	687 8.7%	917 10.3%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	Data on all outcomes were collected from national registries.
Arm/Group Title	Conventional		suPAR
Arm/Group Description	no suPAR measurement. Standard care.		suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
All Cause Mortality
	Conventional		suPAR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1126/7901 (14.3%)		1241/8900 (13.9%)
Serious Adverse Events
	Conventional		suPAR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7901 (0%)		0/8900 (0%)
Other (Not Including Serious) Adverse Events
	Conventional		suPAR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	700/7901 (8.9%)		777/8900 (8.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New cancer diagnosis	700/7901 (8.9%)	700	777/8900 (8.7%)	777

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.