NCT03873701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

November 2, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2019

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

October 30, 2018

Last Update Submit

April 24, 2019

Conditions

Keywords

bedside ultrasonographyemergency department

Outcome Measures

Primary Outcomes (1)

  • Ultrasonographic hydronephrosis

    Ultrasonographic hydronephrosis defined by \> 1cm pelvic dilation

    All included patient undergo bedside ultrasonography within 4 hours after admission

Secondary Outcomes (1)

  • Clinical consequence of bedside ultrasonographic result

    Within 4 hours after admission

Interventions

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.

Also known as: Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years
  • Radiological ultrasonographic examination already performed
  • Patients who are not able to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense Universitetshospital

Odense C, 5000, Denmark

Location

MeSH Terms

Conditions

HydronephrosisPyelonephritisEmergencies

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephritis, InterstitialNephritisPyelitisDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Annmarie T Lassen, Professor

    Forskningsenheden FAM OUH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc med

Study Record Dates

First Submitted

October 30, 2018

First Posted

March 13, 2019

Study Start

November 2, 2018

Primary Completion

April 5, 2019

Study Completion

April 8, 2019

Last Updated

April 25, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations