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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 PediatricsNCT06034717

Primary Patency in Pediatric Patients With Hemodialysis Access

An observational study of 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, run by Alaa Gameil Abd El-salam Hussien at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 6 to 18 yearsHealthy volunteers can take part
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Oct 2022to 28 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • ) 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.

Who cannot join

  • 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
  • -

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Assuit university hospital

    Asyut

Other trials in Egypt

About this study

Official title: Mid Term&Short Term Outcomes in Pediatric Patients With Hemodialysis Access

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: from 1october 2022to 28september 2023

Secondary outcomes (1)
  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

    Measured: from 1october 2022to 28september 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start1 Oct 2022
  3. Primary completion28 Sep 2023 (estimated)
  4. Study completion28 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06034717
Sponsor's protocol ID
observational
Status last verified
Sep 2023
First submitted
6 Sep 2023
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of 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, run by Alaa Gameil Abd El-salam Hussien at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: from 1october 2022to 28september 2023). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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