Clinical trial NCT06040736: Point-of-care Ultrasound to Assess Hydronephrosis in Patients With Acute Kidney Injury in the Emergency Department
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Urinary Tract Obstruction
Keywords: Point-of-care ultrasound
Acute kidney injury
Hydronephrosis
urinary tract obstruction
Emergency Medicine
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the emergency department of Montpellier university hospital

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Vesical globe
* Polycystic kidney disease
* Known renal tumor
* Horseshoe kidney

Primary outcomes:
measure: Performance of pont of care ultrasound (POCUS) for the diagnosis of hydronephrosis
timeFrame: 1 day (Emergency department (ED) length of stay)
Secondary outcomes:
measure: Level of agreement between ED Pocus and central radiology imaging for the diagnosis of hydronephrosis
timeFrame: 1 day (ED length of stay)
measure: Risk Factors for POCUS misdiagnosis
timeFrame: 1 day (ED length of stay)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: university hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Mustapha SEBBANE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: