Trial Outcomes & Findings for Risk Stratification in Acute Care: The Meaning of suPAR Measurement in Triage (NCT NCT02643459)
NCT ID: NCT02643459
Last Updated: 2021-03-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20000 participants
Primary outcome timeframe
10 months after the inclusions period ends mortality data will be assessed
Results posted on
2021-03-09
Participant Flow
Participant milestones
| Measure |
Conventional
no suPAR measurement. Standard care.
|
suPAR
suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
|
|---|---|---|
|
Overall Study
STARTED
|
7901
|
8900
|
|
Overall Study
COMPLETED
|
7901
|
8900
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Risk Stratification in Acute Care: The Meaning of suPAR Measurement in Triage
Baseline characteristics by cohort
| Measure |
Conventional
n=7901 Participants
no suPAR measurement. Standard care.
|
suPAR
n=8900 Participants
suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
|
Total
n=16801 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 20.7 • n=99 Participants
|
60.4 years
STANDARD_DEVIATION 20.8 • n=107 Participants
|
60.6 years
STANDARD_DEVIATION 20.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4175 Participants
n=99 Participants
|
4689 Participants
n=107 Participants
|
8864 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3726 Participants
n=99 Participants
|
4211 Participants
n=107 Participants
|
7937 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7901 Participants
n=99 Participants
|
8900 Participants
n=107 Participants
|
16801 Participants
n=206 Participants
|
|
Region of Enrollment
Denmark
|
7901 participants
n=99 Participants
|
8900 participants
n=107 Participants
|
16801 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 10 months after the inclusions period ends mortality data will be assessedTime frame starts at the beginning of the index admission, defined as first admission in the study period. Patients will be followed using central registers.
Outcome measures
| Measure |
Conventional
n=7901 Participants
no suPAR measurement. Standard care.
|
suPAR
n=8900 Participants
suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
|
|---|---|---|
|
All Cause Mortality
|
1126 Participants
|
1241 Participants
|
SECONDARY outcome
Timeframe: 1 months after index admission mortality data will assessedMortality within 30 days
Outcome measures
| Measure |
Conventional
n=7901 Participants
no suPAR measurement. Standard care.
|
suPAR
n=8900 Participants
suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
|
|---|---|---|
|
All Cause Mortality
|
319 Participants
|
359 Participants
|
SECONDARY outcome
Timeframe: 24 hoursHow many patients are discharged directly from the ED
Outcome measures
| Measure |
Conventional
n=7901 Participants
no suPAR measurement. Standard care.
|
suPAR
n=8900 Participants
suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
|
|---|---|---|
|
Number of Discharges From the Emergency Room Within 24 Hours
|
3934 Participants
|
4352 Participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of Participants with Admissions to the Medical War
Outcome measures
| Measure |
Conventional
n=7901 Participants
no suPAR measurement. Standard care.
|
suPAR
n=8900 Participants
suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
|
|---|---|---|
|
Number of Admissions to the Medical Ward
|
3500 Participants
|
3738 Participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of Participants with transfer to the ICU
Outcome measures
| Measure |
Conventional
n=7901 Participants
no suPAR measurement. Standard care.
|
suPAR
n=8900 Participants
suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
|
|---|---|---|
|
Number of Patients With an Admission to the Intensive Care Unit
|
1027 Participants
|
1157 Participants
|
SECONDARY outcome
Timeframe: 10 months after inclusion period endsOutcome measures
| Measure |
Conventional
n=7901 Participants
no suPAR measurement. Standard care.
|
suPAR
n=8900 Participants
suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
|
|---|---|---|
|
Number of Patients With New Cancer Diagnosis in Control vs Intervention Groups
|
687 Participants
|
917 Participants
|
SECONDARY outcome
Timeframe: 30 daysLength of stay in days during the admission
Outcome measures
| Measure |
Conventional
n=7901 Participants
no suPAR measurement. Standard care.
|
suPAR
n=8900 Participants
suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
|
|---|---|---|
|
Length of Stay During Admission.
|
4.53 Days
Standard Error 8.7
|
4.39 Days
Standard Error 8.27
|
SECONDARY outcome
Timeframe: 90 daysPatients will be followed using central registers. All new admissions within 90 days of the same patient is defined as readmissions.
Outcome measures
| Measure |
Conventional
n=7901 Participants
no suPAR measurement. Standard care.
|
suPAR
n=8900 Participants
suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
|
|---|---|---|
|
Number of Readmissions
|
687 Participants
|
917 Participants
|
Adverse Events
Conventional
Serious events: 0 serious events
Other events: 700 other events
Deaths: 1126 deaths
suPAR
Serious events: 0 serious events
Other events: 777 other events
Deaths: 1241 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional
n=7901 participants at risk
no suPAR measurement. Standard care.
|
suPAR
n=8900 participants at risk
suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New cancer diagnosis
|
8.9%
700/7901 • Number of events 700 • 1 year
Data on all outcomes were collected from national registries.
|
8.7%
777/8900 • Number of events 777 • 1 year
Data on all outcomes were collected from national registries.
|
Additional Information
Dr. Martin Schultz
Herlev Hospital, Department of Cardiology
Phone: 004538683868
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place