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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05569109
Collaborator
(none)
120
1
13
9.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: doppler ultrasound

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

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
av Fistula Patency Loss as a Cause of Fistula Failure and Its Relation to Hyperphosphatemia in Chronic Hemodialysis Patients
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
av fistula patency loss with hperphosphatemia

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

Device: doppler ultrasound
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

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

Outcome Measures

Primary Outcome Measures

  1. measurement of early av fistula patency loss [baseline]

    early measurement of av fistula patency loss using doppler ultrasound to decrease the fistula failure rate

Secondary Outcome Measures

  1. measurement if there is a relation between fistula patency loss and hyperphosphatemia [baseline]

    analysis if a high serum phosphate level leads to arteriovenous fistula patency loss

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Assiut U Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kerollos Refaat Labeeb, M.B.B.CH , M.Sc, Assiut University
ClinicalTrials.gov Identifier:
NCT05569109
Other Study ID Numbers:
  • av fistula and phosphate
First Posted:
Oct 6, 2022
Last Update Posted:
Oct 6, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kerollos Refaat Labeeb, M.B.B.CH , M.Sc, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2022