Emergent DialysisNCT05337384
Sonographic Venous Doppler Imaging in End-Stage Renal Disease
An observational study of Emergent Dialysis and Venous Doppler Ultrasound, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Patients with end-stage renal disease (ESRD) may visit to emergency services for urgent hemodialysis or other reasons. Hemodialysis application in emergency conditions is generally not as optimal as in dialysis units. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Emergent Dialysis, Venous Doppler Ultrasound
- What is being tested?
- Sonography
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Dec 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 end-stage renal disease
Who may be able to join
- Patients with end-stage renal disease
Who cannot join
- Who are pregnant,
- With cirrhosis and liver malignancy,
- Who do not give consent for the study,
- Arrest presentation
- Unable to scan in the first six hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Venous Doppler Imaging in Predicting the Indication of Emergency Dialysis in Patients With End-Stage Renal Disease
Patients with end-stage renal disease (ESRD) may visit to emergency services for urgent hemodialysis or other reasons. Hemodialysis application in emergency conditions is generally not as optimal as in dialysis units. It takes time to provide suitable conditions (personnel and equipment), the length of stay of patients in the emergency services is prolonged, and this may cause disruption of patient care in these areas where rapid patient care is provided. Therefore, the management of ESRD patients continues to be one of the serious problems faced by emergency physicians.
Sonographic evaluation of the venous system (vena cava inferior, hepatic, portal and renal vein) may be an alternative diagnostic method for need for urgent hemodialysis. Hereby, patients who don't need hemodialysis safely can be discharged from emergency services. 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 researchers aimed to determine the diagnostic value of sonographic venous Doppler imaging the need for urgent hemodialysis in ESRD patients in the emergency services.
- Conditions
- Emergent Dialysis, Venous Doppler Ultrasound
- Being tested
- Sonography
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 for the need for urgent hemodialysis
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 posted20 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergent DialysisStudies 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
- 40 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
- NCT05337384
- Sponsor's protocol ID
- GaziU2
- Status last verified
- Jan 2023
- First submitted
- 13 Apr 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Venous Doppler Imaging in Predicting the Indication of Emergency Dialysis in Patients With End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT05337384
- Acronym / sponsor ID
- GaziU2
- Conditions
- Emergent Dialysis, Venous Doppler Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 20 Apr 2022 (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.
Patients with end-stage renal disease (ESRD) may visit to emergency services for urgent hemodialysis or other reasons. Hemodialysis application in emergency conditions is generally not as optimal as in dialysis units. It takes time to provide suitable conditions (personnel and equipment), the length of stay of patients in the emergency services is prolonged, and this may cause disruption of patient care in these areas where rapid patient care is provided. Therefore, the management of ESRD patients continues to be one of the serious problems faced by emergency physicians.
Sonographic evaluation of the venous system (vena cava inferior, hepatic, portal and renal vein) may be an alternative diagnostic method for need for urgent hemodialysis. Hereby, patients who don't need hemodialysis safely can be discharged from emergency services. 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 researchers aimed to determine the diagnostic value of sonographic venous Doppler imaging the need for urgent hemodialysis in ESRD patients in the emergency services.
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 end-stage renal disease
Key inclusion criteria (1 listed)
- Patients with end-stage renal disease
Key exclusion criteria (5 listed)
- Who are pregnant,
- With cirrhosis and liver malignancy,
- Who do not give consent for the study,
- Arrest presentation
- Unable to scan in the first six hours
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 for the need for urgent hemodialysis
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 26 Jan 2023.
- Individual participant dataSharing planned: No
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 Emergent Dialysis and Venous Doppler Ultrasound, 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 5 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 26 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 for the need for urgent hemodialysis (time frame: 1 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 26 Jan 2023.