av Fistula Patency Loss as a Cause of Fistula Failure and Hyperphosphatemia

AV Fistula Clinical Trial

Official title:

av Fistula Patency Loss as a Cause of Fistula Failure and Its Relation to Hyperphosphatemia in Chronic Hemodialysis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05569109
• Other study ID #: av fistula and phosphate
• Status: Not yet recruiting
• Start date: December 1, 2022
• Est. completion date: January 2024

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: kerollos labeeb
• Phone: +0201228182636
• Email: kerels011315[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult patients more than 18 years old with end stage renal disease on regular hemodialysis using arteriovenous fistula

Exclusion Criteria:

• : 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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• AV Fistula
• Fistula
• Hyperphosphatemia

Intervention

Device:
• doppler ultrasound
doppler ultrasound on arteriovenous fistula in hemodialysis patients

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Assiut U	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Cozzolino M, Gallieni M, Brancaccio D. The mechanisms of hyperphosphatemia-induced vascular calcification. Int J Artif Organs. 2008 Dec;31(12):1002-3. — View Citation

Huijbregts 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. — View Citation

MacRae 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. — View Citation

Manne 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. — View Citation

Moghazy KM. Value of color Doppler sonography in the assessment of hemodialysis access dysfunction. Saudi J Kidney Dis Transpl. 2009 Jan;20(1):35-43. — View Citation

Tüysüz 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of early av fistula patency loss	early measurement of av fistula patency loss using doppler ultrasound to decrease the fistula failure rate	baseline
Secondary	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	baseline