ValidityNCT07073508
The Validity of the Evaluation of Renal Artery Duplex in Critically Ill Acute Kidney Injury Patients
An observational study of Validity and Renal Artery Duplex, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to assess the clinical relevance of renal artery duplex ultrasound in critically ill patients with acute kidney injury (AKI) in terms of the renal resistive index (RRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Validity, Renal Artery Duplex, Critically Ill Acute Kidney Injury
- What is being tested?
- Renal Artery Duplex
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: One hundred patients admitted to the intensive care unit (ICU), all the studied populations will be diagnosed to have AKI, with no past medical history of chronic renal disease.
Who may be able to join
- Patients age >18 years.
- Both sexes.
- Patients within 24 hours after intensive care unit (ICU) admission.
Who cannot join
- Patients presented with poor abdominal echogenicity.
- Chronic kidney disease, especially with estimated creatinine clearance less than 30 ml/min/1.73m.
- Patients with dialysis dependency.
- Patients with renal transplantation.
- Patients with known renal artery stenosis.
- If there is a pregnancy.
- Patients with any congenital kidney diseases as mono-kidney, anatomic kidney abnormalities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11591
Mahmoud R Basiony, Master, 00201094726393, mohamoud.rabie2014@gmail.com
Mohamed M Shokeir, MD
About this study
This study aims to assess the clinical relevance of renal artery duplex ultrasound in critically ill patients with acute kidney injury (AKI) in terms of the renal resistive index (RRI).
Read the detailed description
Diagnosis of acute kidney injury (AKI) is based on rising creatinine as late phenomenon. Intrarenal vasoconstriction occurs earlier, so measuring flow resistance in the renal circulation, renal resistive index (RRI), could become part of vital organ function assessment using Doppler ultrasound.
- Being tested
- Renal Artery Duplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Artery DuplexOther
Renal artery duplex will be performed to all patients in terms of renal resistivity index (RRI).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients diagnosed with acute kidney injury (AKI). Receives: Other: Renal Artery Duplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal resistivity index (RRI)
The renal resistivity index (RRI) will be assessed in patients with acute kidney injury (AKI) who require intensive care unit (ICU) admission within 24 hours.
Measured: 1 week post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 May 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ValidityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud rabie, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073508
- Sponsor's protocol ID
- FMASU MD51/2024
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of the Evaluation of Renal Artery Duplex in Critically Ill Acute Kidney Injury Patients
- ClinicalTrials.gov ID
- NCT07073508
- Acronym / sponsor ID
- FMASU MD51/2024
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 18 Jul 2025 (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.
This study aims to assess the clinical relevance of renal artery duplex ultrasound in critically ill patients with acute kidney injury (AKI) in terms of the renal resistive index (RRI).
Detailed description
Diagnosis of acute kidney injury (AKI) is based on rising creatinine as late phenomenon. Intrarenal vasoconstriction occurs earlier, so measuring flow resistance in the renal circulation, renal resistive index (RRI), could become part of vital organ function assessment using Doppler ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Renal Artery DuplexPatients diagnosed with acute kidney injury (AKI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred patients admitted to the intensive care unit (ICU), all the studied populations will be diagnosed to have AKI, with no past medical history of chronic renal disease.
Key inclusion criteria (3 listed)
- Patients age >18 years.
- Both sexes.
- Patients within 24 hours after intensive care unit (ICU) admission.
Key exclusion criteria (7 listed)
- Patients presented with poor abdominal echogenicity.
- Chronic kidney disease, especially with estimated creatinine clearance less than 30 ml/min/1.73m.
- Patients with dialysis dependency.
- Patients with renal transplantation.
- Patients with known renal artery stenosis.
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 |
|---|---|---|
| Renal Artery DuplexRenal artery duplex will be performed to all patients in terms of renal resistivity index (RRI). | Other | Study group |
Primary outcome
Renal resistivity index (RRI)
Time frame: 1 week post-procedure
The renal resistivity index (RRI) will be assessed in patients with acute kidney injury (AKI) who require intensive care unit (ICU) admission within 24 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Validity and Renal Artery Duplex, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Jul 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud R Basiony, Master (00201094726393, mohamoud.rabie2014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal resistivity index (RRI) (time frame: 1 week post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2025.