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

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ClinicalTrials.gov Identifier: NCT06040736
Recruitment Status : Recruiting
First Posted : September 18, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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
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
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Study Type : Observational
Estimated 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 : July 2, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Performance of pont of care ultrasound (POCUS) for the diagnosis of hydronephrosis [ Time Frame: 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 :
  1. Level of agreement between ED Pocus and central radiology imaging for the diagnosis of hydronephrosis [ Time Frame: 1 day (ED length of stay) ]
    Agreement between Pocus and radiology examination (radiology ultrasound (US) or Computed Tomography (CT) for the diagnosis of hydronephrosis

  2. Risk Factors for POCUS misdiagnosis [ Time Frame: 1 day (ED length of stay) ]
    Factors associated with misdiagnosis of hydronephrosis at POCUS


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to the emergency department of Montpellier university hospital
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06040736


Contacts
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Contact: Mustapha SEBBANE, MD, PhD +33 (4) 67 33 79 74 m-sebbane@chu-montpellier.fr
Contact: Sophie LEFEBVRE, PhD +33 (4) 67 33 85 76 s-lefebvre@chu-montpellier.fr

Locations
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France
university hospital of Montpellier Recruiting
Montpellier, France
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Mustapha SEBBANE, MD, PhD University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT06040736    
Other Study ID Numbers: RECHMPL21_0158
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Point-of-care ultrasound
Acute kidney injury
Hydronephrosis
urinary tract obstruction
Emergency Medicine
Additional relevant MeSH terms:
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Acute Kidney Injury
Hydronephrosis
Emergencies
Wounds and Injuries
Disease Attributes
Pathologic Processes
Renal Insufficiency
 Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases