Acute Kidney FailureIRASMUNCT06190522
Diagnosis of Acute Obstructive Renal Failure by Clinical Ultrasound Performed by the Emergency Physician.
An observational study of Acute Kidney Failure, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure
- What is being tested?
- Emergency physician clinical ultrasound
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2021to 6 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute renal failure recruited during their visit to the emergency department where the ultrasound will be performed
Who may be able to join
- 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))
Who cannot join
- Patients unable to express their non-objection
- Patients who have undergone a kidney transplant
- Dialysis patients
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Acute Kidney Failure
- Being tested
- Emergency physician clinical ultrasound
- Keywords
- acute renal failure, ultrasound, diagnosis
- Medical subject headings
- Acute Kidney Injury, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency physician clinical ultrasoundDiagnostic test
Clinical ultrasound by emergency doctor consisting in obtaining frontal sections of the 2 kidneys and a transverse section of the bladder
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute renal failure | Patients receiving a clinical ultrasound by the on-site emergency physician trained in the technique Receives: Diagnostic Test: Emergency physician clinical ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start6 Jul 2021
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic BALEN, PH, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190522
- Sponsor's protocol ID
- RC31/21/0118
- Other IDs
- 2021-A00777-34
- Acronym
- IRASMU
- Status last verified
- Jan 2024
- First submitted
- 14 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21782075Liano 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.
PubMed 8872955Pathan 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.
PubMed 29663580Bellomo 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.
PubMed 15312219Balen 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. 2026 Apr;21(3):1051-1057. doi: 10.1007/s11739-025-03996-2. Epub 2025 Jun 8.
PubMed 40483617
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Acute Obstructive Renal Failure by Clinical Ultrasound Performed by the Emergency Physician.
- ClinicalTrials.gov ID
- NCT06190522
- Acronym / sponsor ID
- IRASMU / RC31/21/0118
- Conditions
- Acute Kidney Failure
- Keywords
- acute renal failure, ultrasound, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute renal failure | – | Diagnostic Test: Emergency physician clinical ultrasoundPatients receiving a clinical ultrasound by the on-site emergency physician trained in the technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute renal failure recruited during their visit to the emergency department where the ultrasound will be performed
Key inclusion criteria (2 listed)
- 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))
Key exclusion criteria (4 listed)
- Patients unable to express their non-objection
- Patients who have undergone a kidney transplant
- Dialysis patients
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency physician clinical ultrasoundClinical ultrasound by emergency doctor consisting in obtaining frontal sections of the 2 kidneys and a transverse section of the bladder | Diagnostic test | Patients with acute renal failure |
Primary outcome
Performance of clinical ultrasound diagnosis by the emergency physician
Time frame: Up to 2 weeks
Performance (sensitivity and specificity) of the diagnosis of an obstructive cause of acute renal failure by emergency physicians performing clinical ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 21782075Hudson 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.
- Background: PubMed 8872955Liano 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.
- Background: PubMed 29663580Pathan 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.
- Background: PubMed 15312219Bellomo 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.
- Derived from this study: PubMed 40483617Balen 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. 2026 Apr;21(3):1051-1057. doi: 10.1007/s11739-025-03996-2. Epub 2025 Jun 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic BALEN, PH principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Failure, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of clinical ultrasound diagnosis by the emergency physician (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06190522, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.