Doppler Ultrasound in Arteriovenous Fistula Preoperative Evaluation and Post-operative Periodic MonitoringNCT05082792
The Role of Doppler Ultrasound in Assessment of Local Factors Affecting Maturation of Arteriovenous Fistula in Hemodialysis Patient
A study testing doppler ultrasound in people with Doppler Ultrasound in Arteriovenous Fistula Preoperative Evaluation and Post-operative Periodic Monitoring, run by Sohag University at 1 site in Egypt.
Trial summary
the long term survival of the chronic kidney disease (CKD) patients depends on the adequacy of dialysis via good vascular access. the arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Doppler Ultrasound in Arteriovenous Fistula Preoperative Evaluation and Post-operative Periodic Monitoring
- What is being tested?
- doppler ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 31 Mar 2022
- Phase
- Interventional
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CKD and ESRD patients on hemodialysis, in whom native arteriovenous fistula operation is needed
- both sexes are included.
- age group from 15-80years
- upper limb arteriovenous fistula only.
- native arteriovenous fistula.
- surgically succeeded AVF
Who cannot join
- we will exclude:
- patients refused to be in the research.
- Patients with AVF not in the upper limbs.
- Patient of age less than 15years and above 80years.
- patients with synthetic grafts.
Trial locations and contacts
1 site in 1 country.
About this study
the long term survival of the chronic kidney disease (CKD) patients depends on the adequacy of dialysis via good vascular access. the arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis. pre-operative evaluation and periodic monitoring of the AVF after creation with well-defined applied criteria by color doppler ultrasound (CDUS) will help to reduce rate of access failure and achieve better cumulative patency rate of fistulas.
Read the detailed description
In recent years, the improvement in the diagnosis and treatment of chronic kidney disease (CKD) has led to increase the number of patients who need hemodialysis, adequacy of which depends upon the appropriately placed vascular access. Although the arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis, there is still a high rate of failure to mature in clinical practice. To increase the use of AVFs, especially in the co-morbid patients, a thorough pre-operative evaluation and periodic monitoring after AVF creation by color doppler ultrasound (CDUS) allows placement of AVF in higher proportion of patients, and early detection of access dysfunction with subsequent intervention that reduce the rate of access failure.
Doppler ultrasound is the main imaging modality for assessment of dialysis access circuits as its gives information on the morphological criteria and evaluates the inflow and outflow flows. CDUS is non-invasive modality, of low cost, not using ionizing radiation or iodinated contrast media.
- Being tested
- doppler ultrasound
- Keywords
- hemodialysis in CKD. AVF. CDUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doppler ultrasoundDiagnostic test
Doppler ultrasound evaluation of AVF:
- pre-operative evaluation: venous system (patency of central veins and deep venous system, patency of superficial veins, the latter diameter, depth form skin surface, distance from nearby artery, any sizable adjacent tributaries), and arterial system including morphological evaluation (course, diameter, wall alterations, any stenoocclusive disorders) and functional evaluation (flow volume and ability to dilate)
- post-operative evaluation: anastomotic site (type of anastomosis, patency, diameter, PSV and any other morphologic alterations), inflow afferent artery (diameter, PSV and flow volume), outflow efferent vein (patency, diameter, color flow, spectral waveform)
- the first post-operative sonographic evaluation will be done after removal of stiches from the wound and periodic monitoring every one week up until completion of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| doppler US for native AVF in upper limb | Other | creation of native arteriovenous fistula in upper limb in chronic kidney disease patients on hemodialysis Receives: Diagnostic Test: doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
maturation of AVF
maturation is considered successful if the fistula patent has a diameter >6mm, located <6mm maximum depth from skin surface, with PSV 400cm/s, flow volume 600ml/min, within 6 weeks post-surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Oct 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
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 Doppler Ultrasound in Arteriovenous Fistula Preoperative Evaluation and Post-operative Periodic MonitoringStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Areej Mahmoud Ibrahim, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082792
- Sponsor's protocol ID
- Soh-Med-21-10-21
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. Malekmakan L, Haghpanah S, Pakfetrat M et al (2009) Causes of chronic renal failure among Iranian hemodialysis patients. Saudi J Kidney Dis Transpl. 20(3):501-504 2. Shaheen AMFA, Al-Khader A (2005) Epidemiology and causes of end stage renal disease (ESRD). Saudi J Kidney Dis Transplant. 16(3):277-281 3. Malovrh M (2005) Native arteriovenous fistula: preoperative evaluation. Am J Kidney Dis. 39:1218-1225 4. Yerdel MA, Kesenci M, Yazicioglu KM et al (1997) Effect of hemodynamic variables on surgically created arteriovenous fistula flow. Nephrol Dial Transplant. 12(8):1684-1688 5. Wilmink T, Hollingworth L, Powers S et al (2016) Natural history of common autologous arteriovenous fistulae: consequences for planning of dialysis access. Eur J Vasc Endovasc Surg. 51:134-140 6. Lee T (2013) Novel paradigms for dialysis vascular access: downstream vascular biology-is there a final common pathway? Clin J Am Soc Nephrol. 8:2194-2201
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Doppler Ultrasound in Assessment of Local Factors Affecting Maturation of Arteriovenous Fistula in Hemodialysis Patient
- ClinicalTrials.gov ID
- NCT05082792
- Acronym / sponsor ID
- Soh-Med-21-10-21
- Keywords
- hemodialysis in CKD. AVF. CDUS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 19 Oct 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 long term survival of the chronic kidney disease (CKD) patients depends on the adequacy of dialysis via good vascular access. the arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis. pre-operative evaluation and periodic monitoring of the AVF after creation with well-defined applied criteria by color doppler ultrasound (CDUS) will help to reduce rate of access failure and achieve better cumulative patency rate of fistulas.
Detailed description
In recent years, the improvement in the diagnosis and treatment of chronic kidney disease (CKD) has led to increase the number of patients who need hemodialysis, adequacy of which depends upon the appropriately placed vascular access. Although the arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis, there is still a high rate of failure to mature in clinical practice. To increase the use of AVFs, especially in the co-morbid patients, a thorough pre-operative evaluation and periodic monitoring after AVF creation by color doppler ultrasound (CDUS) allows placement of AVF in higher proportion of patients, and early detection of access dysfunction with subsequent intervention that reduce the rate of access failure.
Doppler ultrasound is the main imaging modality for assessment of dialysis access circuits as its gives information on the morphological criteria and evaluates the inflow and outflow flows. CDUS is non-invasive modality, of low cost, not using ionizing radiation or iodinated contrast media.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| doppler US for native AVF in upper limb | Other | Diagnostic Test: doppler ultrasoundcreation of native arteriovenous fistula in upper limb in chronic kidney disease patients on hemodialysis |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- CKD and ESRD patients on hemodialysis, in whom native arteriovenous fistula operation is needed
- both sexes are included.
- age group from 15-80years
- upper limb arteriovenous fistula only.
- native arteriovenous fistula.
Key exclusion criteria (5 listed)
- patients refused to be in the research.
- Patients with AVF not in the upper limbs.
- Patient of age less than 15years and above 80years.
- patients with synthetic grafts.
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 ultrasoundDoppler ultrasound evaluation of AVF: * pre-operative evaluation: venous system (patency of central veins and deep venous system, patency of superficial veins, the latter diameter, depth form skin surface, distance from nearby artery, any sizable adjacent tributaries), and arterial system including morphological evaluation (course, diameter, wall alterations, any stenoocclusive disorders) and functional evaluation (flow volume and ability to dilate) * post-operative evaluation: anastomotic site (type of anastomosis, patency, diameter, PSV and any other morphologic alterations), inflow afferent artery (diameter, PSV and flow volume), outflow efferent vein (patency, diameter, color flow, spectral waveform) * the first post-operative sonographic evaluation will be done after removal of stiches from the wound and periodic monitoring every one week up until completion of 6 weeks | Diagnostic test | doppler US for native AVF in upper limb |
Primary outcome
maturation of AVF
Time frame: 6 months
maturation is considered successful if the fistula patent has a diameter >6mm, located <6mm maximum depth from skin surface, with PSV 400cm/s, flow volume 600ml/min, within 6 weeks post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Background1. Malekmakan L, Haghpanah S, Pakfetrat M et al (2009) Causes of chronic renal failure among Iranian hemodialysis patients. Saudi J Kidney Dis Transpl. 20(3):501-504 2. Shaheen AMFA, Al-Khader A (2005) Epidemiology and causes of end stage renal disease (ESRD). Saudi J Kidney Dis Transplant. 16(3):277-281 3. Malovrh M (2005) Native arteriovenous fistula: preoperative evaluation. Am J Kidney Dis. 39:1218-1225 4. Yerdel MA, Kesenci M, Yazicioglu KM et al (1997) Effect of hemodynamic variables on surgically created arteriovenous fistula flow. Nephrol Dial Transplant. 12(8):1684-1688 5. Wilmink T, Hollingworth L, Powers S et al (2016) Natural history of common autologous arteriovenous fistulae: consequences for planning of dialysis access. Eur J Vasc Endovasc Surg. 51:134-140 6. Lee T (2013) Novel paradigms for dialysis vascular access: downstream vascular biology-is there a final common pathway? Clin J Am Soc Nephrol. 8:2194-2201
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?
A study testing doppler ultrasound in people with Doppler Ultrasound in Arteriovenous Fistula Preoperative Evaluation and Post-operative Periodic Monitoring, run by Sohag 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 6 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: status not confirmed, as of the sponsor's last update on 19 Oct 2021. 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?
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 AVF (time frame: 6 months). 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 NCT05082792, 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 19 Oct 2021.