Bedside Ultrasonography in Acute Patients With Suspected Kidney Involvement

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.

Study Overview

• Status: Completed
• Conditions: Pyelonephritis; Hydronephrosis; Urosepsis
• Intervention / Treatment: Diagnostic test: bedside ultrasonography

• Study Type: Observational
• Enrollment (Actual): 153

Contacts and Locations

Study Locations

• Denmark
  • Odense C, Denmark, 5000
    • Odense Universitetshospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Single-center population collected from patients with contact to the emergency department (ED) at Odense University Hospital (OUH). Convenience sample.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasonographic hydronephrosis	Ultrasonographic hydronephrosis defined by > 1cm pelvic dilation	All included patient undergo bedside ultrasonography within 4 hours after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Odense Patient Data Explorative Network
• Investigators: Study Director: Annmarie T Lassen, Professor, Forskningsenheden FAM OUH

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2018
• Primary Completion (ACTUAL): April 5, 2019
• Study Completion (ACTUAL): April 8, 2019

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (ACTUAL): March 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: emergency department; bedside ultrasonography
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Nephritis; Nephritis, Interstitial; Pyelitis; Pyelonephritis; Hydronephrosis
• Other Study ID Numbers: 65004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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