AV FistulaNCT05569109
av Fistula Patency Loss as a Cause of Fistula Failure and Hyperphosphatemia
An observational study of AV Fistula, run by Assiut University at 1 site in Egypt.
Trial summary
Assessment of arteriovenous fistula patency loss which leads to av fistula failure and its relation to high serum phosphate level in chronic hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- AV Fistula
- What is being tested?
- doppler ultrasound
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to Jan 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - adult patients more than 18 years old with end stage renal disease on regular hemodialysis using arteriovenous fistula
Who may be able to join
- adult patients more than 18 years old with end stage renal disease on regular hemodialysis using arteriovenous fistula
Who cannot join
- : patients less than 18 years, patients with peripheral artery diseases, access failure occurred within the first 2 months after fistula surgery, AVF failure was related to an infectious complication and patients with arteriovenous grafts.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Assiut U
Asyut
kerollos labeeb, 01228182636, kerels011315@med.aun.edu.eg
About this study
Official title: av Fistula Patency Loss as a Cause of Fistula Failure and Its Relation to Hyperphosphatemia in Chronic Hemodialysis Patients
Assessment of arteriovenous fistula patency loss which leads to av fistula failure and its relation to high serum phosphate level in chronic hemodialysis patients.
Read the detailed description
End-stage renal disease is a chronic disease requiring treatment with dialysis or renal transplantation. Patients require an adequate vascular access for hemodialysis (HD). Autologous arteriovenous fistula (AVF) is gold standard to maintain vascular access for HD . Vascular access-related complications can lead to patient morbidity and reduction of patient quality of life.The complication rate related to permanent HD vascular access remains relatively high and access related problems are responsible for 50% of the hospitalization of dialysis patients. Secondary failures are not rare and in need of adequate attention and care. Once the AVF has been placed. It is recommended that serial monitoring of the AVF should be done for long term effective function. Delays in preventing complications may lead to AVF dysfunction. However, little is known about the factors determining long term prognosis of an AVF.
Primary patency (intervention-free access survival) was defined as the interval from time of access placement to any intervention designed to maintain or reestablish patency or to access thrombosis or the time of measurement of patency. Assisted primary patency (thrombosis-free access survival) was defined as the interval from time of access placement to access thrombosis or time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of a patent access. Secondary patency (access survival until abandonment) was defined as the interval from time of access placement to access abandonment or time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to reestablish the functionality of thrombosed access .
In patients having chronic renal failure (CRF), several changes occur in bone metabolism due to the development of secondary hyperparathyroidism. There are increased calcium and phosphate release from bones to the blood, causing the deposition of calcium and phosphate in the intima-media layer of arterial wall and eventuating vascular calcification in these patients. The deposition of these electrolytes increases the risk of cerebrovascular and coronary complications as well. Thus, a decrease in the quality of fistula occurs in these tracts utilized frequently at the arteriovenous fistula (AVF) operations.
- Conditions
- AV Fistula
- Being tested
- doppler ultrasound
- Keywords
- hyperphosphatemia
- Medical subject headings
- Arteriovenous Fistula, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doppler ultrasoundDevice
doppler ultrasound on arteriovenous fistula in hemodialysis patients
| Study group | Role | What they receive |
|---|---|---|
| av fistula patency loss with hperphosphatemia | hemodialysis patients with av fistula patency loss by doppler ultrasound and hyperphosphatemia Receives: Device: doppler ultrasound | |
| av fistula patency loss with normal phosphate level | hemodialysis patients with av fistula patency loss by doppler ultrasound and normal phosphate level Receives: Device: doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of early av fistula patency loss
early measurement of av fistula patency loss using doppler ultrasound to decrease the fistula failure rate
Measured: baseline
Secondary outcomes (1)
measurement if there is a relation between fistula patency loss and hyperphosphatemia
analysis if a high serum phosphate level leads to arteriovenous fistula patency loss
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Dec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (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 AV 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerollos Refaat Labeeb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569109
- Sponsor's protocol ID
- av fistula and phosphate
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tuysuz ME, Dedemoglu M. Calcium phosphate product level as a predictor for arteriovenous fistula re-operations in patients with chronic renal failure. Vascular. 2019 Jun;27(3):284-290. doi: 10.1177/1708538118814611. Epub 2018 Nov 21.
PubMed 30463499Cozzolino M, Gallieni M, Brancaccio D. The mechanisms of hyperphosphatemia-induced vascular calcification. Int J Artif Organs. 2008 Dec;31(12):1002-3. doi: 10.1177/039139880803101203.
PubMed 19115191Manne V, Vaddi SP, Reddy VB, Dayapule S. Factors influencing patency of Brescia-Cimino arteriovenous fistulas in hemodialysis patients. Saudi J Kidney Dis Transpl. 2017 Mar-Apr;28(2):313-317. doi: 10.4103/1319-2442.202759.
PubMed 28352013MacRae JM, Dipchand C, Oliver M, Moist L, Lok C, Clark E, Hiremath S, Kappel J, Kiaii M, Luscombe R, Miller LM; Canadian Society of Nephrology Vascular Access Work Group. Arteriovenous Access Failure, Stenosis, and Thrombosis. Can J Kidney Health Dis. 2016 Sep 27;3:2054358116669126. doi: 10.1177/2054358116669126. eCollection 2016.
PubMed 28270918Moghazy KM. Value of color Doppler sonography in the assessment of hemodialysis access dysfunction. Saudi J Kidney Dis Transpl. 2009 Jan;20(1):35-43.
PubMed 19112217Huijbregts HJ, Bots ML, Wittens CH, Schrama YC, Moll FL, Blankestijn PJ; CIMINO study group. Hemodialysis arteriovenous fistula patency revisited: results of a prospective, multicenter initiative. Clin J Am Soc Nephrol. 2008 May;3(3):714-9. doi: 10.2215/CJN.02950707. Epub 2008 Feb 6.
PubMed 18256379
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- av Fistula Patency Loss as a Cause of Fistula Failure and Its Relation to Hyperphosphatemia in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05569109
- Acronym / sponsor ID
- av fistula and phosphate
- Conditions
- AV Fistula
- Keywords
- hyperphosphatemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 6 Oct 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.
Assessment of arteriovenous fistula patency loss which leads to av fistula failure and its relation to high serum phosphate level in chronic hemodialysis patients.
Detailed description
End-stage renal disease is a chronic disease requiring treatment with dialysis or renal transplantation. Patients require an adequate vascular access for hemodialysis (HD). Autologous arteriovenous fistula (AVF) is gold standard to maintain vascular access for HD . Vascular access-related complications can lead to patient morbidity and reduction of patient quality of life.The complication rate related to permanent HD vascular access remains relatively high and access related problems are responsible for 50% of the hospitalization of dialysis patients. Secondary failures are not rare and in need of adequate attention and care. Once the AVF has been placed. It is recommended that serial monitoring of the AVF should be done for long term effective function. Delays in preventing complications may lead to AVF dysfunction. However, little is known about the factors determining long term prognosis of an AVF.
Primary patency (intervention-free access survival) was defined as the interval from time of access placement to any intervention designed to maintain or reestablish patency or to access thrombosis or the time of measurement of patency. Assisted primary patency (thrombosis-free access survival) was defined as the interval from time of access placement to access thrombosis or time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of a patent access. Secondary patency (access survival until abandonment) was defined as the interval from time of access placement to access abandonment or time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to reestablish the functionality of thrombosed access .
In patients having chronic renal failure (CRF), several changes occur in bone metabolism due to the development of secondary hyperparathyroidism. There are increased calcium and phosphate release from bones to the blood, causing the deposition of calcium and phosphate in the intima-media layer of arterial wall and eventuating vascular calcification in these patients. The deposition of these electrolytes increases the risk of cerebrovascular and coronary complications as well. Thus, a decrease in the quality of fistula occurs in these tracts utilized frequently at the arteriovenous fistula (AVF) operations.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| av fistula patency loss with hperphosphatemia | – | Device: doppler ultrasoundhemodialysis patients with av fistula patency loss by doppler ultrasound and hyperphosphatemia |
| av fistula patency loss with normal phosphate level | – | Device: doppler ultrasoundhemodialysis patients with av fistula patency loss by doppler ultrasound and normal phosphate level |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - adult patients more than 18 years old with end stage renal disease on regular hemodialysis using arteriovenous fistula
Key inclusion criteria (1 listed)
- adult patients more than 18 years old with end stage renal disease on regular hemodialysis using arteriovenous fistula
Key exclusion criteria (1 listed)
- : patients less than 18 years, patients with peripheral artery diseases, access failure occurred within the first 2 months after fistula surgery, AVF failure was related to an infectious complication and patients with arteriovenous 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 on arteriovenous fistula in hemodialysis patients | Device | av fistula patency loss with hperphosphatemia, av fistula patency loss with normal phosphate level |
Primary outcome
measurement of early av fistula patency loss
Time frame: baseline
early measurement of av fistula patency loss using doppler ultrasound to decrease the fistula failure rate
1 secondary outcome
measurement if there is a relation between fistula patency loss and hyperphosphatemia
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Background: PubMed 30463499Tuysuz ME, Dedemoglu M. Calcium phosphate product level as a predictor for arteriovenous fistula re-operations in patients with chronic renal failure. Vascular. 2019 Jun;27(3):284-290. doi: 10.1177/1708538118814611. Epub 2018 Nov 21.
- Background: PubMed 19115191Cozzolino M, Gallieni M, Brancaccio D. The mechanisms of hyperphosphatemia-induced vascular calcification. Int J Artif Organs. 2008 Dec;31(12):1002-3. doi: 10.1177/039139880803101203.
- Background: PubMed 28352013Manne V, Vaddi SP, Reddy VB, Dayapule S. Factors influencing patency of Brescia-Cimino arteriovenous fistulas in hemodialysis patients. Saudi J Kidney Dis Transpl. 2017 Mar-Apr;28(2):313-317. doi: 10.4103/1319-2442.202759.
- Background: PubMed 28270918MacRae JM, Dipchand C, Oliver M, Moist L, Lok C, Clark E, Hiremath S, Kappel J, Kiaii M, Luscombe R, Miller LM; Canadian Society of Nephrology Vascular Access Work Group. Arteriovenous Access Failure, Stenosis, and Thrombosis. Can J Kidney Health Dis. 2016 Sep 27;3:2054358116669126. doi: 10.1177/2054358116669126. eCollection 2016.
- Background: PubMed 19112217Moghazy KM. Value of color Doppler sonography in the assessment of hemodialysis access dysfunction. Saudi J Kidney Dis Transpl. 2009 Jan;20(1):35-43.
- Background: PubMed 18256379Huijbregts HJ, Bots ML, Wittens CH, Schrama YC, Moll FL, Blankestijn PJ; CIMINO study group. Hemodialysis arteriovenous fistula patency revisited: results of a prospective, multicenter initiative. Clin J Am Soc Nephrol. 2008 May;3(3):714-9. doi: 10.2215/CJN.02950707. Epub 2008 Feb 6.
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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.
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 AV Fistula, run by Assiut 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 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 6 Oct 2022. 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?
Contact kerollos labeeb (+0201228182636, kerels011315@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of early av fistula patency loss (time frame: baseline). 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 NCT05569109, 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 6 Oct 2022.