Point-of-care Ultrasound to Assess Hydronephrosis in Patients With Acute Kidney Injury in the Emergency Department

Recruiting

• Conditions: Urinary Tract Obstruction; Acute Kidney Injury

• Registration Number: NCT06040736
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2020-07-02
• Status Verified: 2023-07
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-12
• Last Update Submitted: 2023-09-15
• Study First Posted: 2023-09-18
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of pont of care ultrasound (POCUS) for the diagnosis of hydronephrosis	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)

Secondary Outcome Measures

Name	Time	Method
Level of agreement between ED Pocus and central radiology imaging for the diagnosis of hydronephrosis	1 day (ED length of stay)	Agreement between Pocus and radiology examination (radiology ultrasound (US) or Computed Tomography (CT) for the diagnosis of hydronephrosis
Risk Factors for POCUS misdiagnosis	1 day (ED length of stay)	Factors associated with misdiagnosis of hydronephrosis at POCUS

Trial Locations

Locations (1)

university hospital of Montpellier; 🇫🇷 Montpellier, France