Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients
1 other identifier
interventional
477
1 country
2
Brief Summary
Arteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Immediate-access arteriovenous grafts (IAAVGs) is a new modality in which dialysis can be started immediately to avoid complications of central venous catheters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2020
CompletedFirst Submitted
Initial submission to the registry
May 9, 2020
CompletedFirst Posted
Study publicly available on registry
May 14, 2020
CompletedJuly 23, 2020
July 1, 2020
2.7 years
May 9, 2020
July 22, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Primary Patency
Patency of hemodialysis access
1 year
Success rate
successful graft procedure
24 hours
Secondary Outcomes (1)
Complications rate
1 year
Study Arms (2)
Immediate-access Arteriovenous Grafts
EXPERIMENTALImmediate-access Arteriovenous Grafts as a vascular access for hemodialysis patients
Standard Arteriovenous Grafts
ACTIVE COMPARATORStandard Arteriovenous Grafts as a vascular access for hemodialysis patients
Interventions
Arteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Immediate-access arteriovenous grafts (IAAVGs) is a new modality in which dialysis can be started immediately to avoid complications of central venous catheters.
Eligibility Criteria
You may qualify if:
- Adult hemodialysis patients
You may not qualify if:
- Significant cardiorespiratory comorbidities.
- Peripheral vascular disease.
- Pregnancy or lactation.
- Severe bleeding disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Faculty of Medicine, Zagazig University
Zagazig, Egypt
Faculty of Medicine
Zagazig, Egypt
Related Publications (1)
Tawfik AM, Zidan MH, Salem A, Salem A. A randomized controlled study of early versus standard cannulation of arteriovenous grafts in hemodialysis patients. J Vasc Surg. 2022 Mar;75(3):1047-1053. doi: 10.1016/j.jvs.2021.08.106. Epub 2021 Sep 30.
PMID: 34601044DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Tawfik, PhD
Faculty of Medicine, Zagazig University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2020
First Posted
May 14, 2020
Study Start
August 15, 2017
Primary Completion
April 10, 2020
Study Completion
April 10, 2020
Last Updated
July 23, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share