Hemodialysis Access FailureNCT04098159
Role of Regular Surveillance on Maintenance of Patency of an Arteriovenous Access
A study testing duplex ultrasound in people with Hemodialysis Access Failure, run by Assiut University.
Trial summary
Chronic Kidney disease (CKD) is a worldwide public health problem that classified into five stages (1). End stage renal disease (CDK stage 5) patients require a well-functioning vascular access (VA) for successful hemodialysis treatment (2). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Access Failure
- What is being tested?
- duplex ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Jul 2021
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ESRD Patients have functioning or failing VAs (AVFs or AVGs).
Who cannot join
- ESRD patients have infected or failed VAs .
- patientrefusal .
Trial locations and contacts
No sites are listed yet.
About this study
Chronic Kidney disease (CKD) is a worldwide public health problem that classified into five stages (1). End stage renal disease (CDK stage 5) patients require a well-functioning vascular access (VA) for successful hemodialysis treatment (2). Types of VA include arteriovenous fistulae (AVFs) and arteriovenous grafts (AVGs). A vascular access is liable to early or late complications, and ultimately access failure. A meta-analysis showed that a 17% mean early access failure However recent studies have shown higher failure rates of up to 46%, with one year patencies between 52% to 83% (3). Low VA flow, thrombosis and loss of patency may result in under-dialysis that leads to increased morbidity, mortality and healthcare expenditure (4). In the majority of VAs, stenoses develop over variable intervals causing VA thrombosis and failure (5). If early detected and corrected, VA function and patency can be preserved and under-dialysis can be minimized or avoided. The aim of this study is to find out the role of periodic surveillance of VA in the detection of VA dysfunction and correctable lesions that may necessitate pre-emptive interventions to maintain VA patency and prevent VA loss
- Conditions
- Hemodialysis Access Failure
- Being tested
- duplex ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duplex ultrasoundDevice
Also called diagnostic venography, angioplasty, surgery
regular duplex follow up every three months with subsequent intervention either diagnostic venography , angioplasty or surgery according to the type of the lesion
| Study group | Role | What they receive |
|---|---|---|
| ESRD Patients have functioning or failing VAs (AVFs or AVGs). | Experimental | Not described Receives: Device: duplex ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number, type and technical success rate for elective interventions
Measured: within one year of creation of the VA
Secondary outcomes (3)
secondary patency rate of the Arteriovenous Access after elective intervention
Measured: within one year of creation of the VA
number , type of complication that resulted from elective interventions
Measured: within one year of creation of the VA
primary patency rate of newly created Arteriovenous Access in assiut governorate
Measured: within one year of creation of the VA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis Access FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Rashed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098159
- Sponsor's protocol ID
- Surveillance of an A-V access
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gray RJ, Sacks D, Martin LG, Trerotola SO. Reporting standards for percutaneous interventions in dialysis access. Technology Assessment Committee. J Vasc Interv Radiol. 1999 Nov-Dec;10(10):1405-15. doi: 10.1016/s1051-0443(99)70252-6. No abstract available.
PubMed 10584659Lee T, Mokrzycki M, Moist L, Maya I, Vazquez M, Lok CE; North American Vascular Access Consortium. Standardized definitions for hemodialysis vascular access. Semin Dial. 2011 Sep-Oct;24(5):515-24. doi: 10.1111/j.1525-139X.2011.00969.x. Epub 2011 Sep 9.
PubMed 21906166National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
PubMed 11904577Hakim RM, Breyer J, Ismail N, Schulman G. Effects of dose of dialysis on morbidity and mortality. Am J Kidney Dis. 1994 May;23(5):661-9. doi: 10.1016/s0272-6386(12)70276-7.
PubMed 8172208Tordoir J, Canaud B, Haage P, Konner K, Basci A, Fouque D, Kooman J, Martin-Malo A, Pedrini L, Pizzarelli F, Tattersall J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG on Vascular Access. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii88-117. doi: 10.1093/ndt/gfm021. No abstract available.
PubMed 17507428Besarab A. Advances in end-stage renal diseases 2000. Access monitoring methods. Blood Purif. 2000;18(4):255-9. doi: 10.1159/000014445. No abstract available.
PubMed 10965064
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Regular Surveillance on Maintenance of Patency of an Arteriovenous Access
- ClinicalTrials.gov ID
- NCT04098159
- Acronym / sponsor ID
- Surveillance of an A-V access
- Conditions
- Hemodialysis Access Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 23 Sep 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.
Chronic Kidney disease (CKD) is a worldwide public health problem that classified into five stages (1). End stage renal disease (CDK stage 5) patients require a well-functioning vascular access (VA) for successful hemodialysis treatment (2). Types of VA include arteriovenous fistulae (AVFs) and arteriovenous grafts (AVGs). A vascular access is liable to early or late complications, and ultimately access failure. A meta-analysis showed that a 17% mean early access failure However recent studies have shown higher failure rates of up to 46%, with one year patencies between 52% to 83% (3). Low VA flow, thrombosis and loss of patency may result in under-dialysis that leads to increased morbidity, mortality and healthcare expenditure (4). In the majority of VAs, stenoses develop over variable intervals causing VA thrombosis and failure (5). If early detected and corrected, VA function and patency can be preserved and under-dialysis can be minimized or avoided. The aim of this study is to find out the role of periodic surveillance of VA in the detection of VA dysfunction and correctable lesions that may necessitate pre-emptive interventions to maintain VA patency and prevent VA loss
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESRD Patients have functioning or failing VAs (AVFs or AVGs). | Experimental | Device: duplex ultrasound |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ESRD Patients have functioning or failing VAs (AVFs or AVGs).
Key exclusion criteria (2 listed)
- ESRD patients have infected or failed VAs .
- patientrefusal .
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 |
|---|---|---|
| duplex ultrasoundAlso: diagnostic venography, angioplasty, surgeryregular duplex follow up every three months with subsequent intervention either diagnostic venography , angioplasty or surgery according to the type of the lesion | Device | ESRD Patients have functioning or failing VAs (AVFs or AVGs). |
Primary outcome
Number, type and technical success rate for elective interventions
Time frame: within one year of creation of the VA
3 secondary outcomes
secondary patency rate of the Arteriovenous Access after elective intervention
Time frame: within one year of creation of the VA
number , type of complication that resulted from elective interventions
Time frame: within one year of creation of the VA
primary patency rate of newly created Arteriovenous Access in assiut governorate
Time frame: within one year of creation of the VA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Background: PubMed 10584659Gray RJ, Sacks D, Martin LG, Trerotola SO. Reporting standards for percutaneous interventions in dialysis access. Technology Assessment Committee. J Vasc Interv Radiol. 1999 Nov-Dec;10(10):1405-15. doi: 10.1016/s1051-0443(99)70252-6. No abstract available.
- Background: PubMed 21906166Lee T, Mokrzycki M, Moist L, Maya I, Vazquez M, Lok CE; North American Vascular Access Consortium. Standardized definitions for hemodialysis vascular access. Semin Dial. 2011 Sep-Oct;24(5):515-24. doi: 10.1111/j.1525-139X.2011.00969.x. Epub 2011 Sep 9.
- Background: PubMed 11904577National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
- Background: PubMed 8172208Hakim RM, Breyer J, Ismail N, Schulman G. Effects of dose of dialysis on morbidity and mortality. Am J Kidney Dis. 1994 May;23(5):661-9. doi: 10.1016/s0272-6386(12)70276-7.
- Background: PubMed 17507428Tordoir J, Canaud B, Haage P, Konner K, Basci A, Fouque D, Kooman J, Martin-Malo A, Pedrini L, Pizzarelli F, Tattersall J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG on Vascular Access. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii88-117. doi: 10.1093/ndt/gfm021. No abstract available.
- Background: PubMed 10965064Besarab A. Advances in end-stage renal diseases 2000. Access monitoring methods. Blood Purif. 2000;18(4):255-9. doi: 10.1159/000014445. No abstract available.
Related trials for Hemodialysis Access Failure
Recruiting
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
End Stage Renal Disease (ESRD), Kidney Failure
Recruiting
The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion
Venous Stenosis, Venous Occlusion
Recruiting
Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
End Stage Renal Disease
Not yet recruiting
DialysisBot: AI Chatbot for Hemodialysis Self-Management
Chatbot-Based Training, Hemodialysis
Not yet recruiting
PATH-03 Paraguay Feasibility Study
Kidney Disease, End-Stage
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.
Questions about this trial
What is this clinical trial studying?
A study testing duplex ultrasound in people with Hemodialysis Access Failure, 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 2 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 24 Sep 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?
Contact ahmed m rashed, resident (00201064252719, ahmedrashed9933@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number, type and technical success rate for elective interventions (time frame: within one year of creation of the VA). 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 NCT04098159, which also lists 6 linked publications.
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 24 Sep 2019.