An observational study in Acute Kidney Injury and Urinary Tract Obstruction, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by University Hospital, Montpellier · Observational
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.
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's enrollment of 155 is close to the median of 160 across 814 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
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Patients admitted to the emergency department of Montpellier university hospital
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Exclusion Criteria:
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
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)
Time frame: 1 day (Emergency department (ED) length of stay)
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
Time frame: 1 day (ED length of stay)
Risk Factors for POCUS misdiagnosis
Factors associated with misdiagnosis of hydronephrosis at POCUS
Time frame: 1 day (ED length of stay)
Plan to share: No
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Ran from Jul 2020 to primary completion in Sep 2023, 38 months.
Of 349 non-industry observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 38 months is above that.
Counting every sponsor, half of 364 studies reached it within 24 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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