Clinical trial NCT05556915: Benefit of Ultrasound Guidance in Arteriovenous Fistula (AVF) Cannulation in Pediatric Hemodialysis
Official title: Intérêt De L'échoguidage Dans Les Ponctions De Fistule Artério-veineuse En Hémodialyse Pédiatrique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Fistula Cannulation
Keywords: Arteriovenous fistula AVF
Pediatric hemodialysis
Cannulation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 7
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, randomized clinical study comparing two AVF cannulation methodes (conventional vs ultrasound-guided method) in pediatric patients with end-stage renal disease undergoing hemodialysis therapy.
Primary purpose: OTHER

Brief summary: The arteriovenous fistula (AVF) is the reference hemodialysis vascular access for both adult and pediatric patients. The cannulation quality is decisive for the quality of the dialysis. Difficult AVF cannulations are more frequent in pediatrics than in adults. Recent studies in adults have shown that ultrasound-guided AVF cannulation improves the cannulation quality and therefore the quality of dialysis. This study aims to prove that ultrasound-guided AVF cannulation in children will improve the quality of dialysis overall.

Detailed description: The European and American recommandations emphasize that the arteriovenous fistula (AVF) is the first choice vascular access in hemodialysis for both adult and pediatric patients. Indeed, infections and thrombotic complications are lower with an AVF than with a central venous catheter. In addition, the efficiency of dialysis is better in patients with AVF in both pediatric and adult patients.

The pediatric population has its own characteristics. On the one hand, the size of the vessels, in particular in patients weighing less than 20 kilos, complicates the creation of the AVF. On the other hand, the time for AVF maturation in children (corresponding to the time required between the creation of the AVF and its use) is much higher than that of the adult population. These specific anatomical characteristics partly explain the more frequent AVF cannulation difficulties in pediatric patients.

Inadequate dialysis is considered to be a session in which the therapy goals were not achieved. This rate of inadequate dialysis is estimated at 8-10% in children due to vascular access problem, whereas this rate is only 1 to 5% in adults. There is also an increase in side effects related to these pediatric AVF cannulation difficulties (trauma, hematoma, edema following diffusion, etc.) responsible for inadequate dialysis and, in the long term, AVF dysfunction (stenosis, thrombosis).

The preservation of the vascular access by means of new cannulation techniques aimed at limiting trauma is therefore a primary objective in pediatric hemodialysis. The introduction of new cannulation methods as well as the training of nurses/childcare workers in the various puncture techniques would thus make it possible to improve the quality of dialysis sessions, the lifespan of AVFs, to increase the number of puncture sites and reduce the number of punctures per session and the occurrence of complications.

Recently, the ultrasound-guided AVF cannulation technique has shown promising results in adults with regard to the prevention of vascular access complications, the feeling of pain and the obtaining of adequate dialysis.

A recent review points to the need to confirm the benefit of ultrasound-guided cannulation through randomized studies, the current data being promising but needing to be confirmed. To date, no data concerning the benefit of ultrasound-guided cannulation in pediatrics is available in the literature. Our project will therefore be the first research to compare 2 AVF cannulation methods in pediatric hemodialysis. The hypothesis adopted is that the AVF cannulation using ultrasound guidance in children undergoing dialysis will allow an overall improvement of dialysis quality, a reduction of complication occurrence and an improvement of patient comfort.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients ˂ 18 years of age at enrollment
* Patients with end-stage renal disease undergoing hemodialysis therapy
* Patients carrying an arteriovenous fistula created more than 6 weeks before enrollment
* Prior agreement of the patient and their legal representative by signing the parent's informed consent form
* Patients affiliated to social security system

Exclusion Criteria:

* Non-matured arteriovenous fistula according to the referring pediatrician
* Patients undergoing dialysis at least partly through a central venous catheter
* Estimated duration of dialysis less than 1 month in the investigation center
* Participation in other intervention research

Primary outcomes:
measure: Compare the rate of inadequate dialysis after ultrasound-guided AVF cannulation vs. conventional cannulation in pediatric patients (<18 years) with end-stage renal disease undergoing hemodialysis therapy.
timeFrame: 12 months
Secondary outcomes:
measure: Number of cannulations required for the insertion of the 2 dialysis catheters
timeFrame: During procedure
measure: The time required for the insertion of the 2 catheters
timeFrame: During procedure
measure: The occurrence of cannulation complications
timeFrame: During procedure
measure: The occurrence of dialysis incidents caused by catheters dysfunction
timeFrame: During procedure
measure: Patient satisfaction
timeFrame: 30 days, 90 days, 180 days and 12 months after enrollment
measure: Patient comfort
timeFrame: During the procedure
measure: Patient comfort
timeFrame: During the procedure
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Jean Philippe BOUDET
role: PRINCIPAL_INVESTIGATOR
References: