Sensitivity and Specificity of Urinary Dipstick in Emergency Departments

• Sponsor: Sonderborg Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04059211
• Collaborator: (none)
• Enrollment: 178
• Location: 1
• Actual Duration (Months): 11.4
• Patients Per Site Per Month: 15.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Proteinuria	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 Design

• Study Type: Observational
• Actual Enrollment: 178 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Sensitivity and Specificity of Urinary Dipstick in Emergency Departments
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Sep 18, 2019
• Actual Study Completion Date: Mar 13, 2020

Outcome Measures

Primary Outcome Measures

1. Sensitivity and specificity of urinary dipstick for proteinuria on emergency departments [5 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sonderborg Hospital	Sønderborg	Southern Denmark	Denmark	6400

Sponsors and Collaborators

• Sonderborg Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jan Dominik Kampmann, Medical doctor, Sonderborg Hospital
• ClinicalTrials.gov Identifier: NCT04059211
• Other Study ID Numbers: S-20190013
• First Posted: Aug 16, 2019
• Last Update Posted: Oct 22, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jan Dominik Kampmann, Medical doctor, Sonderborg Hospital: urinary dipstick; emergency department
• Additional relevant MeSH terms: Proteinuria; Emergencies

Study Results

No Results Posted as of Oct 22, 2020