Acute Kidney InjuryNCT06040736
Point-of-care Ultrasound to Assess Hydronephrosis in Patients With Acute Kidney Injury in the Emergency Department
An observational study of Acute Kidney Injury and Urinary Tract Obstruction, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Urinary Tract Obstruction
- How many people
- 155 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2020to 30 Sep 2023
- 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: Patients admitted to the emergency department of Montpellier university hospital
Who may be able to join
- Patient with acute kidney injury defined by changes in serum creatinine (sCr) level between the index sCr at ED admission and pre and/or post sCr controls (Kidney Disease Improving Global Outcome criteria)
- Patient who does not oppose to the use of their data
Who cannot join
- Vesical globe
- Polycystic kidney disease
- Known renal tumor
- Horseshoe kidney
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point-of-care Ultrasound to Assess Hydronephrosis in Patients Presenting With Acute Kidney Injury in the Emergency Department: a Prospective Comparative Pragmatic Study
Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic management. This observational study aims at assessing the accuracy of point-of-care ultrasound (POCUS), performed by the emergency physician (EP) for the detection of dilatation or distension of the kidney secondary to urinary tract obstruction, in emergency department patients presenting with acute kidney injury (AKI). Participants will undergo a bedside POCUS of the urinary tract by the EP followed by central imaging evaluation by a radiologist (either ultrasound or renal computed tomography (CT) or both). Researchers will compare both diagnosis. Study hypothesis is that trained emergency physicians can rapidly and reliably diagnose renal tract obstruction at POCUS in the context of AKI.
Read the detailed description
Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic management. Hydronephrosis is a dilatation or distension of the kidney secondary to urinary tract obstruction. It can be diagnosed at ultrasonography or computed tomography. Assessment of the renal tract and detection of hydronephrosis is a core component of the emergency medicine Point-of-Care Ultrasound (Pocus) curriculum. The primary objective of this study is to compare the performance of point-of-care ultrasound performed by the emergency physician to that of central radiology imaging (US or CT) by a radiologist, to diagnose hydronephrosis in patients presenting with AKI in the ED. All imaging exams will be performed as part of routine evaluation, Pocus will be carried out by a trained EP blinded from radiology imaging results.
- Conditions
- Acute Kidney Injury, Urinary Tract Obstruction
- Keywords
- Point-of-care ultrasound, Acute kidney injury, Hydronephrosis, urinary tract obstruction, Emergency Medicine
- Medical subject headings
- Acute Kidney Injury, Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute kidney injury | Emergency department patients presenting with acute kidney injury, regardless of their complaint for ED admission. AKI is defined based on increase in serum creatinine (SCr) levels according to Kdigo criteria Patients will undergo both a bedside point of care ultrasonography and a central radiology imaging evaluation of hydronephrosis as part of routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of pont of care ultrasound (POCUS) for the diagnosis of hydronephrosis
Performance of POCUS for the detection of hydronephrosis compared to radiology imaging as the gold standard (Sensitivity, Specificity, Negative Predictive Value, Positive Predicted Value)
Measured: 1 day (Emergency department (ED) length of stay)
Secondary outcomes (2)
Level of agreement between ED Pocus and central radiology imaging for the diagnosis of hydronephrosis
Agreement between Pocus and radiology examination (radiology ultrasound (US) or Computed Tomography (CT) for the diagnosis of hydronephrosis
Measured: 1 day (ED length of stay)
Risk Factors for POCUS misdiagnosis
Factors associated with misdiagnosis of hydronephrosis at POCUS
Measured: 1 day (ED length of stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start2 Jul 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mustapha SEBBANE, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040736
- Sponsor's protocol ID
- RECHMPL21_0158
- Status last verified
- Aug 2025
- First submitted
- 4 Sep 2023
- Last updated
- 29 Aug 2025
- 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 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Ultrasound to Assess Hydronephrosis in Patients Presenting With Acute Kidney Injury in the Emergency Department: a Prospective Comparative Pragmatic Study
- ClinicalTrials.gov ID
- NCT06040736
- Acronym / sponsor ID
- RECHMPL21_0158
- Conditions
- Acute Kidney Injury, Urinary Tract Obstruction
- Keywords
- Point-of-care ultrasound, Acute kidney injury, Hydronephrosis, urinary tract obstruction, Emergency Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 18 Sep 2023 (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.
Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic management. This observational study aims at assessing the accuracy of point-of-care ultrasound (POCUS), performed by the emergency physician (EP) for the detection of dilatation or distension of the kidney secondary to urinary tract obstruction, in emergency department patients presenting with acute kidney injury (AKI). Participants will undergo a bedside POCUS of the urinary tract by the EP followed by central imaging evaluation by a radiologist (either ultrasound or renal computed tomography (CT) or both). Researchers will compare both diagnosis. Study hypothesis is that trained emergency physicians can rapidly and reliably diagnose renal tract obstruction at POCUS in the context of AKI.
Detailed description
Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic management. Hydronephrosis is a dilatation or distension of the kidney secondary to urinary tract obstruction. It can be diagnosed at ultrasonography or computed tomography. Assessment of the renal tract and detection of hydronephrosis is a core component of the emergency medicine Point-of-Care Ultrasound (Pocus) curriculum. The primary objective of this study is to compare the performance of point-of-care ultrasound performed by the emergency physician to that of central radiology imaging (US or CT) by a radiologist, to diagnose hydronephrosis in patients presenting with AKI in the ED. All imaging exams will be performed as part of routine evaluation, Pocus will be carried out by a trained EP blinded from radiology imaging results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute kidney injury | – | –Emergency department patients presenting with acute kidney injury, regardless of their complaint for ED admission. AKI is defined based on increase in serum creatinine (SCr) levels according to Kdigo criteria Patients will undergo both a bedside point of care ultrasonography and a central radiology imaging evaluation of hydronephrosis as part of routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the emergency department of Montpellier university hospital
Key inclusion criteria (2 listed)
- Patient with acute kidney injury defined by changes in serum creatinine (sCr) level between the index sCr at ED admission and pre and/or post sCr controls (Kidney Disease Improving Global Outcome criteria)
- Patient who does not oppose to the use of their data
Key exclusion criteria (4 listed)
- Vesical globe
- Polycystic kidney disease
- Known renal tumor
- Horseshoe kidney
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance of pont of care ultrasound (POCUS) for the diagnosis of hydronephrosis
Time frame: 1 day (Emergency department (ED) length of stay)
Performance of POCUS for the detection of hydronephrosis compared to radiology imaging as the gold standard (Sensitivity, Specificity, Negative Predictive Value, Positive Predicted Value)
2 secondary outcomes
Level of agreement between ED Pocus and central radiology imaging for the diagnosis of hydronephrosis
Time frame: 1 day (ED length of stay)
Risk Factors for POCUS misdiagnosis
Time frame: 1 day (ED length of stay)
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 29 Aug 2025.
- Individual participant dataSharing planned: No
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Mustapha SEBBANE, MD, PhD principal investigator
University Hospital, Montpellier
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 Acute Kidney Injury and Urinary Tract Obstruction, run by University Hospital, Montpellier at 1 site in France.
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 2 inclusion and 4 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 29 Aug 2025. 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 France. 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?
Performance of pont of care ultrasound (POCUS) for the diagnosis of hydronephrosis (time frame: 1 day (Emergency department (ED) length of stay)). 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 29 Aug 2025.