ProteinuriaNCT04059211
Sensitivity and Specificity of Urinary Dipstick in Emergency Departments
An observational study of Proteinuria, run by Sonderborg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Proteinuria
- What is being tested?
- Urinary dipstick
- How many people
- 178 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2019to 13 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients above 18 years of age who were admitted to the emergency department in Sonderborg and who gave their consent.
Who may be able to join
- All patients above 18 years of age who were admitted to the emergency department in Sonderborg and who gave their consent
Who cannot join
- anuria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Proteinuria
- Being tested
- Urinary dipstick
- Keywords
- urinary dipstick, emergency department
- Medical subject headings
- Proteinuria, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary dipstickDiagnostic test
Sensitivity and specificity of urinary dipstick for proteinuria in emergency departments
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of urinary dipstick for proteinuria on emergency departments
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Apr 2019
- Primary completion18 Sep 2019
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonderborg Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jan Dominik Kampmann, Sonderborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059211
- Sponsor's protocol ID
- S-20190013
- Status last verified
- Oct 2020
- First submitted
- 15 Aug 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of Urinary Dipstick in Emergency Departments
- ClinicalTrials.gov ID
- NCT04059211
- Acronym / sponsor ID
- S-20190013
- Conditions
- Proteinuria
- Keywords
- urinary dipstick, emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Sonderborg HospitalOther government
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients above 18 years of age who were admitted to the emergency department in Sonderborg and who gave their consent.
Key inclusion criteria (1 listed)
- All patients above 18 years of age who were admitted to the emergency department in Sonderborg and who gave their consent
Key exclusion criteria (1 listed)
- anuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary dipstickSensitivity and specificity of urinary dipstick for proteinuria in emergency departments | Diagnostic test | – |
Primary outcome
Sensitivity and specificity of urinary dipstick for proteinuria on emergency departments
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proteinuria, run by Sonderborg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of urinary dipstick for proteinuria on emergency departments (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.