Acute Kidney InjuryNCT04470661
Point-of-care Ultrasound for Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Mehmet Ali Aslaner at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to determine prerenal, renal and postrenal diagnoses of patients with acute kidney injury with POCUS performed in the emergency department. Patients who presented to the emergency department and who have acute kidney injury (AKI) according to the KDIGO criteria will be evaluated and patients diagnosed with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Ultrasonography
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 30 Jul 2021
- 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 kidney injury diagnosed in the ED.
Who may be able to join
- AKI diagnosis according to KDIGO criteria
Who cannot join
- Patients with end stage renal failure,
- Failure to perform POCUS in the first two hours of presentation of patient,
- Those with renal malignancy,
- Pregnant women,
- Renal transplantation patients,
- Patients with a single kidney,
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- Those with polycystic kidney disease,
- Patients with nephrostomy,
- Patients who are referred from another center,
- Unable to perform adequate imaging,
- Patients who do not give consent for the study will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Point-of-Care Ultrasound in the Etiology of Acute Kidney Injury
It is aimed to determine prerenal, renal and postrenal diagnoses of patients with acute kidney injury with POCUS performed in the emergency department. Patients who presented to the emergency department and who have acute kidney injury (AKI) according to the KDIGO criteria will be evaluated and patients diagnosed with AKI will be included in the study. The diagnostic accuracy of POCUS with the AKI etiologies of the patients will be evaluated.
- Conditions
- Acute Kidney Injury
- Being tested
- Ultrasonography
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
Point-of-care ultrasound:
- Kidney length and echogenity,
- Bladder scanning
- VCI measures
- Lung B lines and effusion
- Cardiac measurements; EF, TAPSE, TR Vmax, Diameters, LV filling pressures
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic accuracy of POCUS in the patients with AKI
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Aug 2020
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Ali Aslaner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Ali Aslaner, Gazi University
- Investigators
- Mehmet Aslaner, MD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470661
- Sponsor's protocol ID
- GaziU-2
- Status last verified
- Mar 2022
- First submitted
- 9 Jul 2020
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Point-of-Care Ultrasound in the Etiology of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT04470661
- Acronym / sponsor ID
- GaziU-2
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Mehmet Ali AslanerUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 14 Jul 2020 (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.
It is aimed to determine prerenal, renal and postrenal diagnoses of patients with acute kidney injury with POCUS performed in the emergency department. Patients who presented to the emergency department and who have acute kidney injury (AKI) according to the KDIGO criteria will be evaluated and patients diagnosed with AKI will be included in the study. The diagnostic accuracy of POCUS with the AKI etiologies of the patients will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute kidney injury diagnosed in the ED.
Key inclusion criteria (1 listed)
- AKI diagnosis according to KDIGO criteria
Key exclusion criteria (11 listed)
- Patients with end stage renal failure,
- Failure to perform POCUS in the first two hours of presentation of patient,
- Those with renal malignancy,
- Pregnant women,
- Renal transplantation patients,
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 |
|---|---|---|
| UltrasonographyPoint-of-care ultrasound: 1. Kidney length and echogenity, 2. Bladder scanning 3. VCI measures 4. Lung B lines and effusion 5. Cardiac measurements; EF, TAPSE, TR Vmax, Diameters, LV filling pressures | Diagnostic test | – |
Primary outcome
The diagnostic accuracy of POCUS in the patients with AKI
Time frame: One year
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 16 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Mehmet Aslaner, MD principal investigator
Gazi University
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 Injury, run by Mehmet Ali Aslaner at 1 site in Turkey (Türkiye).
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 1 inclusion and 11 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 16 Mar 2022. 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 Turkey (Türkiye). 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?
The diagnostic accuracy of POCUS in the patients with AKI (time frame: One year). 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 16 Mar 2022.