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Active, not recruitingNCT06034717Updated Sep 13, 2023

Primary Patency in Pediatric Patients With Hemodialysis Access

An observational study in The Aim of This Study is to Follow up Short Term "3-6 Months"& Mid Term" 6-12months "Outcomes of Vascular Access" Native and Synthetic "in ESRD Pediatrics, sponsored by Alaa Gameil Abd El-salam Hussien. Active, not recruiting at 1 site in Egypt. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Alaa Gameil Abd El-salam Hussien · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
6 Years to 18 Years
Sex
All
01

Study summary

Vascular access in the pediatric hemodialysis patients is a challenging,but necessary. It requires proper advance planning to assure that the best permanent access is placeds long life span. It is imperative to have a long-term vision to decrease morbidity in this unique patient population.

Read the detailed description

Recent data indicate that the incidence of end stage renal disease (ESRD) in pediatrics has increased over the past two decades[1]. Hemodialysis continues to be the most frequently utilized modality for renal replacement therapy in pediatric ESRD patients One of the most challenging aspects of kidney replacement therapy in children is the creation and maintenance of a functioning vascular access to provide adequate blood flow for uremic solute removal during haemodialysis, whilst minimizing the risk of systemic infections and preserving vascular access choices for future dialysis. There are three common forms of vascularaccess: tunnelled cuffed lines placed in a central vein, arteriovenous fistulas and arteriovenous grafts using prosthetic or biological material. arterio-venous fistula"nativevascularaccesses" are the preferred vascularaccess for children on hemodialysis. Compared with a CVL, a functional artirio-venous fistula is associated with better dialysis adequacy,significantly lowering complication rates and access failure.However, CVLs remain the most frequently used vascular access in all paediatric age groups, despite international recommendations[1-4] pediatrics with ESRD from age (1-6years) start with peritoneal dialysis, and then from age (6-18years) start to use hemodialysis The 'ideal artrio-venous fistula ' is made distally in the non-dominant arm,e.g. a radiocephalic AVF, and suitable vessels are veins>2 mm and arteries > 1 mm [5,6]. Apart from vessel size,many other factors should be considered when deciding which access to create e.g. psychological preparation of the child/parent, surgical expertise, child size/weight, quality of veins,cosmetic concerns for the teenager and hand dominance for the child who wishes to self-cannulate. Maintaining the confidence of the child, parent and dialysis nursing team is vitalwhen forming the access.

thisisdone by the aid ofduplexultrasound to assess size of vein,sizeofartery,patencyofcentralvenoussystem physical examination to assess blood pressure it's important to maintain blood pressure >120,\<160 to allow patency of vascular access.All thisisimportant tominimize/avoid the prolonged use of CVCs due to risks ofinfection and the need for vessel preservation. we need to use good clinical judgment when choosing the appropriate vascular access in each patient.

possible complications that can occur affecting patency of vascular access include:

  1. Stenosis(Stenosis is a common complication which may affect the function of an AVF, it is the main cause of arterio-venousfistula thrombosis and failure) [7]

    . Factors that predispose to the formation of venous neo-intimal hyperplasia and stenoses include the Following: surgical injury, recurrent traumatic cannulaltion (leading to defective vascularre modelling), high blood flow inducing endothelial cell dysfunction andshear stress. Stenoses commonly present clinically with inadequate pump speed, poor dialysis adequacy or a prolonged post-dialysis bleeding time. Physical examination should be correlated with a Doppler ultrasound assessment to investigate any clinically significant stenosis. In the absence of any clinical issues, an arterio-venous fistula stenosis is considered significant if there is >20% reduction from baseline volume

  2. arterio-venous fistula thrombosis Acute vascularaccess thrombosis accounts for 20-25% of all hospitalizations for hemodialysis patients and this leads to considerable morbidity and cost to healthcare providers. [8, 9] An important consideration in preventing early thrombosis peri-arterio-venousfistula formation is to maintain adequate intravascular voume. This can be achieved by reducing the ultrafiltration for a few haemodialysis sessions just after arterio-venous fistula creation and allowing permissive hypertension. Adjusting anti hypertensive treatment in this early post-operative period to maintainbloodpressure(>130). D-dimers may help guide anti-thrombotic therapy and prevent clotting.In a paediatric study, the levels of D-dimers were inversely correlated with patency rates -based protocol to prevent early arterio-venous fistula failure compared with historical controls and showed a lower rate of early thrombosis .
  3. Infections Infection rates for native and synthetic vascularaccess are substantially lower (up to 10 times) than those for CVLs.. Importantly, 80% of the vascular accesses remained functional after treating the infection[10].

Haemodynamic issues High-output cardiac failure is occasionally seen in adults but is uncommon in children and is managed with arterio-venous fistula volume flow reduction . Steal syndrome ] occurs when a significant proportion of cardiac output is diverted from the distalcapillary bed by the proximal arterio-venous fistula, causing distal ischemia [11,12]. This is also rare but may require surgical revision to preserve the access and alleviate the distal ischaemia.

02

Conditions studied

  • The Aim of This Study is to Follow up Short Term "3-6 Months"& Mid Term" 6-12months "Outcomes of Vascular Access" Native and Synthetic "in ESRD Pediatrics
03

In context

Lead sponsor

This is the only study on the registry with Alaa Gameil Abd El-salam Hussien as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

All patients fulfilling the inclusion and exclusion criteria will be included in this study with time frame 1year

Inclusion criteria

  • ) Ages :6-18 2) gender: All 3) Children on regular dialysis 4)children with duplex criteria including: vein >2mm artery>1mm patent , respirophasic central venous system 5) children's parents compliance to follow-up.

Exclusion criteria

Exclusion Criteria:

1)Children with ESRD contraindicated for vascular intervention including: Children with resistance hyper-tention Children with medical history of bleeding tendency Children with hyper-coagulable state 2)children with duplex criteria including: vein fibrotic "\<2mm" artery\<1mm occluded central veins 3)Children's parents not compliance to follow up

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05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
None retained
06

What researchers measure

Primary outcomes

  1. The aim of this study is to follow up Short term "3-6 months"& Mid term" 6-12months "outcomes of Vascular access" native and synthetic "in ESRD pediatrics

    evaluation of short term "3-6months" and Mid term "6-12months" outcomes, patterns of complication in pediatrics with hemodialysis access(time frame one year after surgey) Primary (unassisted) patency The interval from the time of access creation until the first access thrombosis or any intervention to maintain or restore blood flow

    Time frame: from 1october 2022to 28september 2023

Secondary outcomes

  1. 2ry patency

    To identify possible complications\&how to avoid Secondary (cumulative) patency "The time from access creation until access abandonment". Functional secondary patency" The interval from the first successful two-needle cannulation for haemodialysis treatment to access abandonment" possible complications include: 1. Stenosis 2. thrombosis 3. Infections

    Time frame: from 1october 2022to 28september 2023

07

Study locations

1 site
  • Assuit university hospital
    Assiut, Egypt
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06034717
Lead sponsor
Alaa Gameil Abd El-salam Hussien
Collaborators
Assiut University
Responsible party
Alaa Gameil Abd El-salam Hussien (: Alaa Gameil Abd El-salam Hussien, Assiut University) — Sponsor-investigator
First posted
Sep 13, 2023
Start date
Oct 1, 2022
Primary completion
Sep 28, 2023 (estimated)
Completion
Sep 28, 2023 (estimated)
Last update
Sep 13, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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