NCT03397381

Brief Summary

identification of the factors that affect the outcome of arteriovenous fistula in chronic renal failure patients that newly established regular dialysis in Assiut Governorate

  1. 1.To study the factors that influence the outcome of AVF
  2. 2.To evaluate the vascular complications of AVF as occlusion, rupture, aneurysmal dilation and hand ischemia

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

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

December 26, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

January 20, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

December 26, 2017

Last Update Submit

January 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • the number of new renal failure patients with failed arteriovenous fistula as measured with arteriovenous duplex ultrasound imaging peak systolic velocity and end-diastolic velocity in Assiut Governorate

    the arteriovenous fistula will be named fail if one or more of the following 1. No Doppler signal 2. Ratio of peak systolic velocity at stenosis to peak systolic velocity at 2 cm beyond anastomosis (if normal)appearing \>3 3. Intraluminal echogenicity 4. Graft walls appear collapsed

    3 years

Secondary Outcomes (1)

  • the number deaths of renal failure patients on regular dialysis related to AVF complications in Assiut Governorate

    3 years

Eligibility Criteria

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

Chronic renal Failure on regular dialysis

You may qualify if:

  • all adult hemodialysis Patients in Assiut Government are eligible for enrollment if they are newly dialyzed via AVF and agree to participate in the study

You may not qualify if:

  • Patients are not dialyzed with AVF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanan

Asyut, 71515, Egypt

RECRUITING

Related Publications (5)

  • Stolic R. Most important chronic complications of arteriovenous fistulas for hemodialysis. Med Princ Pract. 2013;22(3):220-8. doi: 10.1159/000343669. Epub 2012 Nov 2.

  • Lok CE. Fistula first initiative: advantages and pitfalls. Clin J Am Soc Nephrol. 2007 Sep;2(5):1043-53. doi: 10.2215/CJN.01080307. Epub 2007 Aug 16. No abstract available.

  • Valliant A, McComb K. Vascular Access Monitoring and Surveillance: An Update. Adv Chronic Kidney Dis. 2015 Nov;22(6):446-52. doi: 10.1053/j.ackd.2015.06.002.

  • Hammes M. Hemodynamic and biologic determinates of arteriovenous fistula outcomes in renal failure patients. Biomed Res Int. 2015;2015:171674. doi: 10.1155/2015/171674. Epub 2015 Oct 1.

  • Padberg FT Jr, Calligaro KD, Sidawy AN. Complications of arteriovenous hemodialysis access: recognition and management. J Vasc Surg. 2008 Nov;48(5 Suppl):55S-80S. doi: 10.1016/j.jvs.2008.08.067.

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hanan S Mahrous, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanan S Mahrous, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of Renal dialysis Unit of Assiut Health directorate

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 12, 2018

Study Start

January 20, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

January 11, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations