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Bedside Ultrasonography in Acute Patients With Suspected Kidney Involvement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03873701
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : April 25, 2019
Odense Patient Data Explorative Network
Information provided by (Responsible Party):
Pernilla Goldberg Borggaard, Odense University Hospital

Brief 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.

Condition or disease Intervention/treatment
Hydronephrosis Pyelonephritis Urosepsis Diagnostic Test: bedside ultrasonography

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Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bedside Ultrasonography in Acute Patients With Suspected Kidney Involvement
Actual Study Start Date : November 2, 2018
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Intervention Details:
  • 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.
    Other Name: Ultrasound

Primary Outcome Measures :
  1. Ultrasonographic hydronephrosis [ Time Frame: All included patient undergo bedside ultrasonography within 4 hours after admission ]
    Ultrasonographic hydronephrosis defined by > 1cm pelvic dilation

Secondary Outcome Measures :
  1. Clinical consequence of bedside ultrasonographic result [ Time Frame: Within 4 hours after admission ]
    Clinicians responsible for the primary clinical assessment determine treatment and further examinations before and after the ultrasonographic results.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03873701

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Odense Universitetshospital
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Odense Patient Data Explorative Network
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Study Director: Annmarie T Lassen, Professor Forskningsenheden FAM OUH

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Responsible Party: Pernilla Goldberg Borggaard, BSc med, Odense University Hospital Identifier: NCT03873701     History of Changes
Other Study ID Numbers: 65004
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pernilla Goldberg Borggaard, Odense University Hospital:
bedside ultrasonography
emergency department
Additional relevant MeSH terms:
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Nephritis, Interstitial
Kidney Diseases
Urologic Diseases