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

NCT ID: NCT05569109

Last Updated: 2022-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-01-31

Brief Summary

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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

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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

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AV Fistula

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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av fistula patency loss with hperphosphatemia

hemodialysis patients with av fistula patency loss by doppler ultrasound and hyperphosphatemia

doppler ultrasound

Intervention Type DEVICE

doppler ultrasound on arteriovenous fistula in hemodialysis patients

av fistula patency loss with normal phosphate level

hemodialysis patients with av fistula patency loss by doppler ultrasound and normal phosphate level

doppler ultrasound

Intervention Type DEVICE

doppler ultrasound on arteriovenous fistula in hemodialysis patients

Interventions

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doppler ultrasound

doppler ultrasound on arteriovenous fistula in hemodialysis patients

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Kerollos Refaat Labeeb

M.B.B.CH , M.Sc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine Assiut U

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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kerollos labeeb

Role: CONTACT

+0201228182636

mohamed hafez

Role: CONTACT

+0201061685353

Facility Contacts

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kerollos labeeb

Role: primary

01228182636

References

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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.

Reference Type BACKGROUND
PMID: 30463499 (View on PubMed)

Cozzolino 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.

Reference Type BACKGROUND
PMID: 19115191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28352013 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28270918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19112217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18256379 (View on PubMed)

Other Identifiers

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av fistula and phosphate

Identifier Type: -

Identifier Source: org_study_id

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