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| ID | Type | Description | Link |
|---|---|---|---|
| NL7933 | Other Identifier | Netherlands Trial Registry |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arteriovenous fistula | Active Comparator | Patients allocated to usual care will be treated according to current guidelines on vascular access creation. These guidelines recommend placing autologous arteriovenous fistulas at the most distal site with adequate blood vessels, preferably in the non-dominant arm. Patients who have already been on hemodialysis treatment using a central venous catheter must be operated within 6 months of dialysis initiation. Because the study aims to compare the different surgical strategies for vascular access creation in a real-life situation, the study will not interfere with clinical practice at the study sites. |
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| Arteriovenous graft | Experimental | Patients who are allocated to the arteriovenous graft strategy will have a commercially available prosthetic tube graft implanted for hemodialysis access. Patients who have already been on hemodialysis treatment using a central venous catheter must be operated within 6 months of dialysis initiation. Because the study aims to compare the different surgical strategies for vascular access creation in a real-life situation, the study will not interfere with clinical practice at the study sites. |
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| Central venous catheter | Experimental | Patients who are allocated to the central venous catheter strategy will have a dialysis catheter inserted. Because the study aims to compare the different surgical strategies for vascular access creation in a real-life situation, the study will not interfere with clinical practice at the study sites. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arteriovenous fistula creation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Variable follow-up time of at least 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcome measures (1) | Short Form 12 Dialysis Symptom Index (SF-12 / DSI) | Every 3 months in the first year after enrollment and in the first year after dialysis start |
| Patient-reported outcome measures (2) |
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Inclusion Criteria:
6. Planning to remain in one of participating dialysis centers for at least 1 year 7. Suitable vascular anatomy for all types of vascular access based on duplex ultrasound of the arms, defined as:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarten G Snoeijs, MD PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noordwest Ziekenhuisgroep | Alkmaar | Netherlands | ||||
| Ziekenhuisgroep Twente |
The following end products I will make available for further research and verification:
The embargo period will be as long as required for publication of the research findings.
Interested parties can submit a request for a data set.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan: Version 2 - Signed | May 8, 2026 |
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Parallel group, multicenter randomized controlled trial.
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| Arteriovenous graft placement | Procedure | 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. |
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| Central venous catheter placement | Procedure | 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. |
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Short Form Vascular Access Questionnaire (SF-VAQ)
| 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) | Every 3 months in the first year after enrollment and in the first year after dialysis start |
| Health care costs | Medical Consumption Questionnaire | 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) | 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). | Variable follow-up time of at least 1 year |
| Mortality | All-cause mortality | Variable follow-up time of at least 1 year |
| Primary patency | Outcome measure registered for exploratory analysis | Variable follow-up time of at least 1 year |
| Assisted primary patency | Outcome measure registered for exploratory analysis | Variable follow-up time of at least 1 year |
| Secondary patency | Outcome measure registered for exploratory analysis | Variable follow-up time of at least 1 year |
| Primary functional patency | Outcome measure registered for exploratory analysis | Variable follow-up time of at least 1 year |
| Time until mature vascular access | Outcome measure registered for exploratory analysis | Variable follow-up time of at least 1 year |
| Time until functional vascular access | Outcome measure registered for exploratory analysis | Variable follow-up time of at least 1 year |
| The number of hemodialysis sessions with cannulation difficulties | Outcome measure registered for exploratory analysis | Variable follow-up time of at least 1 year |
| 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 |
| Medisch Centrum Leeuwarden | Leeuwarden | Netherlands |
| Leids Universitair Medisch Centrum | Leiden | Netherlands |
| Maastricht University Medical Center | Maastricht | Netherlands |
| Canisius Wilhelmina Ziekenhuis | Nijmegen | Netherlands |
| Franciscus Gasthuis & Vlietland | Rotterdam | Netherlands |
| Haaglanden Medisch Centrum | The Hague | Netherlands |
| Elisabeth Tweesteden Ziekenhuis | Tilburg | Netherlands |
| Maxima Medisch Centrum | Veldhoven | Netherlands |
| Viecuri Medisch Centrum | Venlo | Netherlands |
| Isala Klinieken | Zwolle | Netherlands |
| Jun 1, 2026 |
| SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Version 1 | Mar 30, 2026 | Mar 31, 2026 | SAP_000.pdf |
| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062905 | Central Venous Catheters |
| ID | Term |
|---|---|
| D062666 | Vascular Access Devices |
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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