NCT06190522

Brief Summary

Acute renal failure is frequently diagnosed in the emergency room during a biological assessment. Its discovery requires determining the cause, which may be either functional, or obstructive. The obstructive cause is responsible for 10% of acute renal failure. It is recommended to start the exploration of this pathology with an ultrasound in search of an obstructive cause. However, ultrasound from the radiologist is not always available. The realization of this ultrasound by the emergency physician would reduce the time to obtain the diagnosis and therefore the time of passage to the emergency room. No study has yet been carried out to validate the performance of this ultrasound by the emergency physician in the case of acute renal failure. This study would validate the diagnostic performance of this ultrasound technique in order to identify as quickly as possible patients with acute renal failure whose cause is obstructive.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

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 6, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

December 14, 2023

Last Update Submit

January 3, 2024

Conditions

Keywords

acute renal failureultrasounddiagnosis

Outcome Measures

Primary Outcomes (1)

  • Performance of clinical ultrasound diagnosis by the emergency physician

    Performance (sensitivity and specificity) of the diagnosis of an obstructive cause of acute renal failure by emergency physicians performing clinical ultrasound

    Up to 2 weeks

Study Arms (1)

Patients with acute renal failure

Patients receiving a clinical ultrasound by the on-site emergency physician trained in the technique

Diagnostic Test: Emergency physician clinical ultrasound

Interventions

Clinical ultrasound by emergency doctor consisting in obtaining frontal sections of the 2 kidneys and a transverse section of the bladder

Patients with acute renal failure

Eligibility Criteria

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

Patients with acute renal failure recruited during their visit to the emergency department where the ultrasound will be performed

You may qualify if:

  • Patients admitted to an emergency structure
  • Patients with acute renal failure (defined by an increase of 1.5 x the baseline serum creatinine value (known or expected according to age and sex))

You may not qualify if:

  • Patients unable to express their non-objection
  • Patients who have undergone a kidney transplant
  • Dialysis patients
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, Haute-Garonne, 31059, France

Location

Related Publications (5)

  • Hudson KB, Sinert R. Renal failure: emergency evaluation and management. Emerg Med Clin North Am. 2011 Aug;29(3):569-85. doi: 10.1016/j.emc.2011.04.005.

    PMID: 21782075BACKGROUND
  • Liano F, Pascual J. Epidemiology of acute renal failure: a prospective, multicenter, community-based study. Madrid Acute Renal Failure Study Group. Kidney Int. 1996 Sep;50(3):811-8. doi: 10.1038/ki.1996.380.

    PMID: 8872955BACKGROUND
  • Pathan SA, Mitra B, Mirza S, Momin U, Ahmed Z, Andraous LG, Shukla D, Shariff MY, Makki MM, George TT, Khan SS, Thomas SH, Cameron PA. Emergency Physician Interpretation of Point-of-care Ultrasound for Identifying and Grading of Hydronephrosis in Renal Colic Compared With Consensus Interpretation by Emergency Radiologists. Acad Emerg Med. 2018 Oct;25(10):1129-1137. doi: 10.1111/acem.13432. Epub 2018 May 28.

    PMID: 29663580BACKGROUND
  • Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.

    PMID: 15312219BACKGROUND
  • Balen F, Drumare L, Laclergerie F, Gaudreau-Simard M, Guy P, Dubucs X. Diagnostic accuracy of point-of-care ultrasonography for obstructive cause in patients with acute kidney injury: a prospective diagnosis cohort. Intern Emerg Med. 2025 Jun 8. doi: 10.1007/s11739-025-03996-2. Online ahead of print.

MeSH Terms

Conditions

Acute Kidney InjuryDisease

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frederic BALEN, PH

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 14, 2023

First Posted

January 5, 2024

Study Start

July 6, 2021

Primary Completion

July 6, 2023

Study Completion

July 6, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations