Arteriovenous FistulaNCT04196478
Role of Color Doppler Ultrasonography in Assessment of Vascular Access Surveillance in Hemodialysis Patients.
An observational study of Arteriovenous Fistula, run by Assiut University.
Trial summary
The aim of this study is to provide an overview of the possible applications of DUS during the maturation and postoperative follow-up of vascular access, with particular emphasis to establish a relationship between doppler Ultrasound parameters including: 1. Flow volume. 2. Outflow vein diameter. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- doppler ultrasound
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Jan 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: Sample size was calculated using Epi-Info 7 software. According to the results of previous study conducted at renal dialysis unit of Assiut university hospital (7) the most common complication occurred in haemodialysis access (A-V fistula) was infected A-V access (23.8%). Based on this prevalence the minimum required sample size for current study is 84 patients. Following assumptions were used to calculate this sample: Target population size = 120 (as number of new haemodialysis patients is 100-120 each year). N.B: in this study we will include all eligible cases at renal dialysis unit of Assiut university i.e., patients of last year (total coverage sample)
Who may be able to join
- ESRD patients on dialysis with heamodialysis vascular access with adult age group (18 years and above).
Who cannot join
- Patients with chronically occluded vascular access with failed surgical or interventional attempts.
About this study
The aim of this study is to provide an overview of the possible applications of DUS during the maturation and postoperative follow-up of vascular access, with particular emphasis to establish a relationship between doppler Ultrasound parameters including:
- Flow volume.
- Outflow vein diameter.
- Outflow vein depth.
- Resistive index.
- Conditions
- Arteriovenous Fistula
- Being tested
- doppler ultrasound
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doppler ultrasoundDevice
a 7.5 MHz ultrasound (US) linear probe is needed, grey-scale ultrasound and Color Doppler and a minimum display facility of the Doppler velocity spectrum for blood flow calculation are mandatory tools.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maturation of arteriovenous fistulas
Assess the role of grey scale and color Doppler US in the early detection of failure in the hemodialysis vascular access.
Maturation and monitoring\ surveillance of arteriovenous fistula.
Measured: 6 weeks duration follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lina Farid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196478
- Sponsor's protocol ID
- DUS in vascular accesses
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 12 Dec 2019
- Results posted
- 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 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Color Doppler Ultrasonography in Assessment of Vascular Access Surveillance in Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT04196478
- Acronym / sponsor ID
- DUS in vascular accesses
- Conditions
- Arteriovenous Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 12 Dec 2019 (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 aim of this study is to provide an overview of the possible applications of DUS during the maturation and postoperative follow-up of vascular access, with particular emphasis to establish a relationship between doppler Ultrasound parameters including:
- Flow volume.
- Outflow vein diameter.
- Outflow vein depth.
- Resistive index.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sample size was calculated using Epi-Info 7 software. According to the results of previous study conducted at renal dialysis unit of Assiut university hospital (7) the most common complication occurred in haemodialysis access (A-V fistula) was infected A-V access (23.8%). Based on this prevalence the minimum required sample size for current study is 84 patients. Following assumptions were used to calculate this sample: Target population size = 120 (as number of new haemodialysis patients is 100-120 each year). N.B: in this study we will include all eligible cases at renal dialysis unit of Assiut university i.e., patients of last year (total coverage sample)
Key inclusion criteria (1 listed)
- ESRD patients on dialysis with heamodialysis vascular access with adult age group (18 years and above).
Key exclusion criteria (1 listed)
- Patients with chronically occluded vascular access with failed surgical or interventional attempts.
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 |
|---|---|---|
| doppler ultrasounda 7.5 MHz ultrasound (US) linear probe is needed, grey-scale ultrasound and Color Doppler and a minimum display facility of the Doppler velocity spectrum for blood flow calculation are mandatory tools. | Device | – |
Primary outcome
Maturation of arteriovenous fistulas
Time frame: 6 weeks duration follow up
Assess the role of grey scale and color Doppler US in the early detection of failure in the hemodialysis vascular access. Maturation and monitoring\ surveillance of arteriovenous fistula.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Maturation of arteriovenous fistulas (time frame: 6 weeks duration follow up). 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 12 Dec 2019.