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

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040736
• Other study ID #: RECHMPL21_0158
• Status: Recruiting
• Start date: July 2, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Montpellier
• Contact: Mustapha SEBBANE, MD, PhD
• Phone: +33 (4) 67 33 79 74
• Email: m-sebbane[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Emergencies
• Hydronephrosis
• Urinary Tract Obstruction
• Wounds and Injuries

Locations

Country	Name	City	State
France	university hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 day (Emergency department (ED) length of stay)
Secondary	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	1 day (ED length of stay)
Secondary	Risk Factors for POCUS misdiagnosis	Factors associated with misdiagnosis of hydronephrosis at POCUS	1 day (ED length of stay)