NCT05569109

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

September 27, 2022

Last Update Submit

October 3, 2022

Conditions

Keywords

hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • measurement if there is a relation between fistula patency loss and hyperphosphatemia

    baseline

Study Arms (2)

av fistula patency loss with hperphosphatemia

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

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

Device: doppler ultrasound

Interventions

doppler ultrasound on arteriovenous fistula in hemodialysis patients

av fistula patency loss with hperphosphatemiaav fistula patency loss with normal phosphate level

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • : 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Assiut U

Asyut, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 30463499BACKGROUND
  • 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.

    PMID: 19115191BACKGROUND
  • 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.

    PMID: 28352013BACKGROUND
  • 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.

    PMID: 28270918BACKGROUND
  • 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.

    PMID: 19112217BACKGROUND
  • 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.

    PMID: 18256379BACKGROUND

MeSH Terms

Conditions

Arteriovenous FistulaHyperphosphatemia

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPhosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.B.B.CH , M.Sc

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 6, 2022

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

October 6, 2022

Record last verified: 2022-10

Locations