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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04059211
Other study ID # S-20190013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date March 13, 2020

Study information

Verified date October 2020
Source Sonderborg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Urinary dipsticks are commonly used in emergency departments since they are a cheap and quick diagnostic tool. However the sensitivity and specificity of urinary dipsticks might be compromised in emergency departments due to fluid imbalance and acute illness itself.


Description:

The study is designed as a prospective observational study on the emergency department in Sonderborg, Southern Denmark. All patients above 18 years of age who have given their consent are included. Urinary dipstick and albumin creatinine ratio is obtained simultaneously within 48 hours after admission on the emergency department. Patient with a positive urinary dipstick will be asked to deliver another urinary dipstick and albumin creatinine ratio 3-8 weeks later. To our knowledge has the specificity and sensitivity of urinary dipstick for protein not been described, yet. Our design will give us the possibility not only to quantify specificity and sensitivity in the acute phase on the emergency department but in the non-acute phase after discharge from the emergency department, as well.


Recruitment information / eligibility

Status Completed
Enrollment 178
Est. completion date March 13, 2020
Est. primary completion date September 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients above 18 years of age who were admitted to the emergency department in Sonderborg and who gave their consent Exclusion Criteria: - anuria

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Urinary dipstick
Sensitivity and specificity of urinary dipstick for proteinuria in emergency departments

Locations

Country Name City State
Denmark Sonderborg Hospital Sønderborg Southern Denmark

Sponsors (1)

Lead Sponsor Collaborator
Sonderborg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of urinary dipstick for proteinuria on emergency departments 5 months
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