Benefit of Ultrasound Guidance in Arteriovenous Fistula (AVF) Cannulation in Pediatric Hemodialysis

NCT05556915 | Completed

• 1 other identifier: RECHMPL21_0526
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Fistula Cannulation

Keywords

Arteriovenous fistula AVF; Pediatric hemodialysis; Cannulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Inadequate dialysis is defined by the presence of one of the following parameters: * Blood flow rate (BFR expressed in ml/min corresponding to the volume of blood in milliliters that flows per minute) less than 80% of adequate blood flow corresponding to a flow ≥ 7 ml per kilograms of weight with a maximum of 300 ml/min * Requirement of single-needle dialysis after 3 cannulation failures * Early discontinuation of hemodialysis * Loss of dialysis circuit during the session * Out of range arterial or venous pressure during dialysis requiring a drop in blood flow rate * Purification coefficient defined by Kt/V \<1.2: K represents the dialyzer clearance of urea (expressed in milliliters/ min and corresponds to the volume of blood in ml cleared of urea per minute ) // t (in minutes) represents the dialysis time duration // V (in milliliters) represents the volume of distribution of urea, and equals the patient's total body water

  12 months

Secondary Outcomes (7)

• Number of cannulations required for the insertion of the 2 dialysis catheters

  During procedure

• The time required for the insertion of the 2 catheters

  During procedure

• The occurrence of cannulation complications

  During procedure

• The occurrence of dialysis incidents caused by catheters dysfunction

  During procedure

• Patient satisfaction

  30 days, 90 days, 180 days and 12 months after enrollment

Study Arms (2)

Ultrasound-guided AVF cannulation method

EXPERIMENTAL

The AVF cannulation is carried out using ultrasoud guidance

Other: Ultrasound-guided AVF cannulation method

Conventional AVF cannulation method

OTHER

The AVF cannulation is carried out by palpation

Other: Conventional AVF cannulation method

Interventions

Ultrasound-guided AVF cannulation method OTHER

For ultrasound-guided cannulation, the same ultrasound device will be used for all patients (TE5-POC ultrasound MINDRAY® system). The ultrasound device will identify the AVF aspect , the location including the depth (distance from the skin surface) , the vessel diameter and guide the cannulation in real-time. The device will be disinfected between uses and covered with a transparent adhesive film to avoid any direct contact with the patient. Sterile gel will be used for the cannulation.

Ultrasound-guided AVF cannulation method

Conventional AVF cannulation method OTHER

The AVF cannulation is carried out by palpation. This technique consists of manually evaluating the position, direction and depth of the fistula in order to determine the puncture site where the 2-dialysis catheters will be inserted. After local asepsis, the AVF is therefore needled at 2 points 5 cm apart.

Conventional AVF cannulation method

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uh Montpellier

Montpellier, Montpellier, 34295, France

Location

Study Officials

• Jean Philippe BOUDET

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 27, 2022
• Study Start: December 3, 2022
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)