HydronephrosisNCT03873701
Bedside Ultrasonography in Acute Patients With Suspected Kidney Involvement
An observational study of Hydronephrosis and Pyelonephritis, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydronephrosis, Pyelonephritis, Urosepsis
- What is being tested?
- bedside ultrasonography
- How many people
- 153 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Nov 2018to 8 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Single-center population collected from patients with contact to the emergency department (ED) at Odense University Hospital (OUH). Convenience sample.
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Radiological ultrasonographic examination already performed
- Patients who are not able to consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hydronephrosis, Pyelonephritis, Urosepsis
- Being tested
- bedside ultrasonography
- Keywords
- bedside ultrasonography, emergency department
- Medical subject headings
- Hydronephrosis, Pyelonephritis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bedside ultrasonographyDiagnostic test
Also called Ultrasound
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic hydronephrosis
Ultrasonographic hydronephrosis defined by > 1cm pelvic dilation
Measured: All included patient undergo bedside ultrasonography within 4 hours after admission
Secondary outcomes (1)
Clinical consequence of bedside ultrasonographic result
Clinicians responsible for the primary clinical assessment determine treatment and further examinations before and after the ultrasonographic results.
Measured: Within 4 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start2 Nov 2018
- Primary completion5 Apr 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydronephrosisStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Responsible party
- Principal investigator, Pernilla Goldberg Borggaard, Odense University Hospital
- Investigators
- Annmarie T Lassen, Professor, Study director, Forskningsenheden FAM OUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873701
- Sponsor's protocol ID
- 65004
- Status last verified
- Apr 2019
- First submitted
- 30 Oct 2018
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Ultrasonography in Acute Patients With Suspected Kidney Involvement
- ClinicalTrials.gov ID
- NCT03873701
- Acronym / sponsor ID
- 65004
- Conditions
- Hydronephrosis, Pyelonephritis, Urosepsis
- Keywords
- bedside ultrasonography, emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single-center population collected from patients with contact to the emergency department (ED) at Odense University Hospital (OUH). Convenience sample.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 years
- Radiological ultrasonographic examination already performed
- Patients who are not able to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bedside ultrasonographyAlso: UltrasoundPatients 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. | Diagnostic test | – |
Primary outcome
Ultrasonographic hydronephrosis
Time frame: All included patient undergo bedside ultrasonography within 4 hours after admission
Ultrasonographic hydronephrosis defined by > 1cm pelvic dilation
1 secondary outcome
Clinical consequence of bedside ultrasonographic result
Time frame: Within 4 hours after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annmarie T Lassen, Professor study director
Forskningsenheden FAM OUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydronephrosis and Pyelonephritis, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic hydronephrosis (time frame: All included patient undergo bedside ultrasonography within 4 hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.