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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03873701
Other study ID # 65004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2, 2018
Est. completion date April 8, 2019

Study information

Verified date April 2019
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the accuracy and implications of the diagnoses and treatment determined by bedside ultrasonography (b-US) of the kidneys compared to current clinical assessment. Potentially diagnosing patients faster and avoiding missing conditions leading to readmission or unnecessary radiation from computed tomography (CT).

This study evaluates the use of b-US as a supplement to clinical evaluation, in an unselected group of patients in the emergency department (ED) with signs of kidney involvement. The b-US of the kidneys is performed by a medical student certified in this technique. The evaluation will be based on data collected from a Danish hospital (Odense University Hospital, OUH) in autumn 2018.


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date April 8, 2019
Est. primary completion date April 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Suspicion of urinary tract infection and one or more of the following:

- Flank pain

- Fever

- Symptoms when voiding

- Creatinine elevation or 20% elevation from known creatinine level elevation

Exclusion Criteria:

- Age < 18 years

- Radiological ultrasonographic examination already performed

- Patients who are not able to consent

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
bedside ultrasonography
Patients suspicious to urinary tract infection with kidney involvement are being examined by ultrasonography to detect hydroneprhosis. The treating clinicians fill out questionnaires to validate the impact of the bedside ultrasonography on the patient care and treatment.

Locations

Country Name City State
Denmark Odense Universitetshospital Odense C

Sponsors (2)

Lead Sponsor Collaborator
Odense University Hospital Odense Patient Data Explorative Network

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ultrasonographic hydronephrosis Ultrasonographic hydronephrosis defined by > 1cm pelvic dilation All included patient undergo bedside ultrasonography within 4 hours after admission
Secondary Clinical consequence of bedside ultrasonographic result Clinicians responsible for the primary clinical assessment determine treatment and further examinations before and after the ultrasonographic results. Within 4 hours after admission
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