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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT06040736

Collaborator

(none)

156

Enrollment

Location

38.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Urinary Tract Obstruction

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

Study Type:

Observational

Anticipated Enrollment :

156 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 2, 2020

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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