Bedside Ultrasonography in Acute Patients With Suspected Kidney Involvement

Hydronephrosis Clinical Trial

Official title:

Bedside Ultrasonography in Acute Patients With Suspected Kidney Involvement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873701
• Other study ID #: 65004
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hydronephrosis
• Pyelonephritis
• Urosepsis

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