Sensitivity and Specificity of Urinary Dipstick in Emergency Departments

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.

Study Overview

• Status: Completed
• Conditions: Proteinuria
• Intervention / Treatment: Diagnostic test: Urinary dipstick

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 178

Contacts and Locations

Study Locations

• Denmark
  • Southern Denmark
    • Sønderborg, Southern Denmark, Denmark, 6400
      • Sonderborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients above 18 years of age who were admitted to the emergency department in Sonderborg and who gave their consent.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of urinary dipstick for proteinuria on emergency departments	5 months

Collaborators and Investigators

• Sponsor: Sonderborg Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): September 18, 2019
• Study Completion (ACTUAL): March 13, 2020

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (ACTUAL): August 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: emergency department; urinary dipstick
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urological Manifestations; Disease Attributes; Urination Disorders; Emergencies; Proteinuria
• Other Study ID Numbers: S-20190013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No