Acute Kidney InjuryNCT04948710
Sonographic Venous Doppler Imaging in Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The first presentations of patients with acute kidney injury (AKI) are usually to the emergency departments. While the mortality rate is 5-10% in uncomplicated AKI, it is between 40-90% in patients hospitalized in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Sonography
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2021to 25 Oct 2022
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency department patients with acute kidney injury
Who may be able to join
- AKI diagnosis
Who cannot join
- Patients
- with end-stage renal failure (stage 4),
- who received 500 mL IV fluid or 40 mg diuretics,
- who are pregnant,
- with renal transplantation,
- with cirrhosis and liver malignancy,
Show all 9Show fewer
- with postrenal AKI,
- who were referred from another center after starting treatment,
- who do not give consent for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Sonographic Venous Doppler Imaging in Acute Kidney Injury
The first presentations of patients with acute kidney injury (AKI) are usually to the emergency departments. While the mortality rate is 5-10% in uncomplicated AKI, it is between 40-90% in patients hospitalized in the intensive care unit. Therefore early diagnosis and treatment of AKI in the emergency department is important in terms of morbidity and mortality.
Sonographic evaluation of the venous system (hepatic, portal and renal vein) may be useful for diagnosis. Studies conducted so far have generally been based on predicting cardiorenal AKI and renal poor outcomes and have been designed in general ICU conditions.
In this study, the investigators aimed to determine the diagnostic value of sonographic venous Doppler imaging in terms of distinguishing subgroups of AKI in patients presented to the emergency department with AKI.
- Conditions
- Acute Kidney Injury
- Being tested
- Sonography
- 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.
SonographyDiagnostic test
Sonographic Venous Doppler Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic accuracy of sonographic venous Doppler imaging in the patients with AKI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start25 Jun 2021
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Gazi 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Aslaner, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948710
- Sponsor's protocol ID
- GaziUniv
- Status last verified
- Jan 2023
- First submitted
- 28 Jun 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aslaner MA, Helvaci O, Haycock K, Kilicaslan I, Yasar E, Cerit MN, Sendur HN, Guz G, Demircan A. Diagnostic accuracy of venous system ultrasound for subtypes of acute kidney injury. Emerg Med J. 2024 Apr 22;41(5):304-310. doi: 10.1136/emermed-2023-213241.
PubMed 38355289
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Sonographic Venous Doppler Imaging in Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT04948710
- Acronym / sponsor ID
- GaziUniv
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 2 Jul 2021 (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.
The first presentations of patients with acute kidney injury (AKI) are usually to the emergency departments. While the mortality rate is 5-10% in uncomplicated AKI, it is between 40-90% in patients hospitalized in the intensive care unit. Therefore early diagnosis and treatment of AKI in the emergency department is important in terms of morbidity and mortality.
Sonographic evaluation of the venous system (hepatic, portal and renal vein) may be useful for diagnosis. Studies conducted so far have generally been based on predicting cardiorenal AKI and renal poor outcomes and have been designed in general ICU conditions.
In this study, the investigators aimed to determine the diagnostic value of sonographic venous Doppler imaging in terms of distinguishing subgroups of AKI in patients presented to the emergency department with AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency department patients with acute kidney injury
Key inclusion criteria (1 listed)
- AKI diagnosis
Key exclusion criteria (9 listed)
- Patients
- with end-stage renal failure (stage 4),
- who received 500 mL IV fluid or 40 mg diuretics,
- who are pregnant,
- with renal transplantation,
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 |
|---|---|---|
| SonographySonographic Venous Doppler Imaging | Diagnostic test | – |
Primary outcome
The diagnostic accuracy of sonographic venous Doppler imaging in the patients with AKI
Time frame: 1 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 31 Jan 2023.
- Derived from this study: PubMed 38355289Aslaner MA, Helvaci O, Haycock K, Kilicaslan I, Yasar E, Cerit MN, Sendur HN, Guz G, Demircan A. Diagnostic accuracy of venous system ultrasound for subtypes of acute kidney injury. Emerg Med J. 2024 Apr 22;41(5):304-310. doi: 10.1136/emermed-2023-213241.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gazi University 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 9 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 31 Jan 2023. 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 sonographic venous Doppler imaging in the patients with AKI (time frame: 1 year). 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 NCT04948710, which also lists 1 linked publication.
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 31 Jan 2023.