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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06190522
Other study ID # RC31/21/0118
Secondary ID 2021-A00777-34
Status Completed
Phase
First received
Last updated
Start date July 6, 2021
Est. completion date July 6, 2023

Study information

Verified date January 2024
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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, i.e. kidney dysfunction, 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. The aim of this research is to evaluate the performance of clinical ultrasound in the diagnosis of an obstructive cause of acute renal failure by the emergency physician.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date July 6, 2023
Est. primary completion date July 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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)) Exclusion Criteria: - Patients unable to express their non-objection - Patients who have undergone a kidney transplant - Dialysis patients - Pregnant women

Study Design


Intervention

Diagnostic Test:
Emergency physician clinical ultrasound
Clinical ultrasound by emergency doctor consisting in obtaining frontal sections of the 2 kidneys and a transverse section of the bladder

Locations

Country Name City State
France CHU de Toulouse Toulouse Haute-Garonne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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