NCT05911451

Optimizing Access Surgery In Senior Hemodialysis Patients

Optimizing Access Surgery In Senior Hemodialysis Patients: a Multicenter Randomized Controlled Trial of Fistulas, Grafts, and Catheters

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The number of elderly hemodialysis patients is growing. Vascular access complications are a major determinant of the quality of life and health care costs for these vulnerable patients. The three different types of vascular access, i.e. autologous arteriovenous fistulas, arteriovenous grafts, and central venous catheters, have never been compared in randomized controlled trials. This project will deliver the much-needed evidence to determine the optimal strategy for vascular access creation in elderly hemodialysis patients in order to deliver better health care at lower costs.

Detailed description

Objective: To compare surgical strategies for vascular access creation in elderly hemodialysis patients. Hypothesis: Arteriovenous grafts and central venous catheters lead to fewer interventions, more quality of life, and lower health care costs than autologous arteriovenous fistulas. Study design: Parallel group, multicenter randomized controlled trial. Study population: Patients \>65 years with a life expectancy \<2 years who are expected to start hemodialysis treatment within 6 months or who have started hemodialysis treatment with a catheter in the past 6 months. Study groups: 1. Autologous arteriovenous fistula creation 2. Arteriovenous graft implantation 3. Central venous catheter placement Sample size calculation: 3x65 patients for superiority with multiplicity correction based on a clinically relevant difference of 0.80 interventions/year. Due to slow enrollment, follow-up time per participant was much longer than anticipated at trial initiation. After enrollment of 166 participants, calculations based on actual event and mortality rates showed that the trial had sufficient statistical power to detect a relative difference in event rate of 0.67, corresponding to an absolute difference below the minimal clinically relevant difference of 0.80 access-related interventions per year. Therefore, enrollment was closed at 166 participants. Data analysis: Poisson regression analysis with time as off-set variable.

Conditions

• Vascular Access Complication
• Hemodialysis Access Failure
• Dialysis Access Malfunction
• Arteriovenous Fistula
• Arteriovenous Graft
• Central Venous Catheter Related Bloodstream Infection

Interventions

Type	Name	Description
PROCEDURE	Arteriovenous fistula creation	It is recommended to create the arteriovenous fistula 3 to 6 months before the expected start of hemodialysis treatment using locoregional anesthesia. It is recommended to use minimal venous and arterial diameters of 2mm for radiocephalic fistulas and 3mm for brachiocephalic and brachiobasilic fistulas. It is recommended to avoid creating an arteriovenous fistula at the same side as a pacemaker, central venous catheter, or arterial stenosis. It is recommended to use the following order of preference for arteriovenous fistula creation: radiocephalic fistula as first choice, brachiocephalic fistula as second choice, and brachiobasilic fistula as third choice.
PROCEDURE	Arteriovenous graft placement	It is recommended to implant the arteriovenous graft 2 weeks before the expected start of hemodialysis treatment under antibiotic prophylaxis. Implantation of an early-cannulation graft is recommended for patients who require more urgent start of hemodialysis to avoid the use of a temporary central venous catheter. It is recommended to use minimal arterial and venous diameters of 3mm and 4mm, respectively. It is recommended to avoid placing an arteriovenous graft at the same side as a pacemaker, central venous catheter, or arterial stenosis.
PROCEDURE	Central venous catheter placement	It is recommended to place a tunneled central venous catheter just before the start of hemodialysis treatment under local anesthesia, with conscious sedation if preferred by the patient. The catheter should preferably be placed in the right internal jugular vein with ultrasound-guided puncture and fluoroscopy control under sterile conditions. According to usual practice at the trial center, catheters may be implanted by surgeons, interventional radiologists, or nephrologists.

Timeline

• Start date: 2019-11-01
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2023-06-22
• Last updated: 2026-04-17

Locations

20 sites across 1 country: Netherlands