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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
166
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.
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.
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.
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Ziekenhuisgroep Twente
Almelo, Netherlands
OLVG
Amsterdam, Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Spaarne Gasthuis
Haarlem, Netherlands
Zuyderland Medisch Centrum
Heerlen, Netherlands
...and 10 more locations
Access-related intervention rate
The number of access-related interventions required for each person-year of hemodialysis treatment. This outcome measure includes all percutaneous access interventions (including central venous catheter placement, removal and guidewire exchange, angioplasty, stent placement, and percutaneous thrombectomy) and surgical access procedures (including initial access creation, subsequent access placements if the first access failed, and surgical revisions to promote maturation or maintain long-term patency, including open thrombectomy) from randomization and treatment assignment until the end of the study period or death.
Time frame: Variable follow-up time of at least 1 year
Patient-reported outcome measures (1)
Short Form 12 Dialysis Symptom Index (SF-12 / DSI)
Time frame: Every 3 months in the first year after enrollment and in the first year after dialysis start
Patient-reported outcome measures (2)
Short Form Vascular Access Questionnaire (SF-VAQ)
Time frame: Every 3 months in the first year after enrollment and in the first year after dialysis start
Patient-reported outcome measures (3)
EuroQol - 5 dimensions - 5 levels (EQ-5D-5L)
Time frame: Every 3 months in the first year after enrollment and in the first year after dialysis start
Health care costs
Medical Consumption Questionnaire
Time frame: Every 3 months in the first year after enrollment and in the first year after dialysis start
Access-related complications
Access-related complications requiring pharmacological treatment (Clavien-Dindo grade 2)
Time frame: Variable follow-up time of at least 1 year
Days in hospital
The number of days admitted to hospital or visiting out-patient clinics for any reason per person-year (including hemodialysis sessions).
Time frame: Variable follow-up time of at least 1 year
Mortality
All-cause mortality
Time frame: Variable follow-up time of at least 1 year
Primary patency
Outcome measure registered for exploratory analysis
Time frame: Variable follow-up time of at least 1 year
Assisted primary patency
Outcome measure registered for exploratory analysis
Time frame: Variable follow-up time of at least 1 year
Secondary patency
Outcome measure registered for exploratory analysis
Time frame: Variable follow-up time of at least 1 year
Primary functional patency
Outcome measure registered for exploratory analysis
Time frame: Variable follow-up time of at least 1 year
Time until mature vascular access
Outcome measure registered for exploratory analysis
Time frame: Variable follow-up time of at least 1 year
Time until functional vascular access
Outcome measure registered for exploratory analysis
Time frame: Variable follow-up time of at least 1 year
The number of hemodialysis sessions with cannulation difficulties
Outcome measure registered for exploratory analysis
Time frame: Variable follow-up time of at least 1 year
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