NCT06040736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2020

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

3.2 years

First QC Date

September 4, 2023

Last Update Submit

August 22, 2025

Conditions

Keywords

Point-of-care ultrasoundAcute kidney injuryHydronephrosisurinary tract obstructionEmergency Medicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Level of agreement between ED Pocus and central radiology imaging for the diagnosis of hydronephrosis

    1 day (ED length of stay)

  • Risk Factors for POCUS misdiagnosis

    1 day (ED length of stay)

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the emergency department of Montpellier university hospital

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university hospital of Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Acute Kidney InjuryHydronephrosis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Mustapha SEBBANE, MD, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 18, 2023

Study Start

July 2, 2020

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations