Optimizing Access Surgery In Senior Hemodialysis Patients

NCT ID: NCT05911451

Last Updated: 2025-05-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arteriovenous fistula

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.

Group Type: ACTIVE_COMPARATOR

Arteriovenous fistula creation

Intervention Type: 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.

Arteriovenous graft

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.

Group Type: EXPERIMENTAL

Arteriovenous graft placement

Intervention Type: 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.

Central venous catheter

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.

Group Type: EXPERIMENTAL

Central venous catheter placement

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Adult patients aged 65 years or older

2. End-stage renal disease with unlikely recovery of kidney function according to the attending nephrologist

3. Hemodialysis is the intended long-term modality of treatment for end-stage renal disease

4. Fit for vascular access surgery as determined by the local multidisciplinary vascular access team 5a. Expected to start hemodialysis treatment within 6 months at the time of treatment assignment; or 5b. Treated with hemodialysis for 6 months or less at the time of treatment assignment using a tunneled or non-tunneled central venous catheter for vascular access

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:

• at least one suitable configuration for an arteriovenous fistula using minimal arterial and venous diameters of 2mm for radiocephalic fistulas and 3mm for brachiocephalic and brachiobasilic fistulas;
• at least one suitable configuration for an arteriovenous graft using minimal arterial and venous diameters of 3mm and 4mm, respectively; and
• at least one open internal jugular vein for a central venous catheter.

Exclusion Criteria

1. Patent arteriovenous fistula or graft already in place

2. Prior unsuccessful arteriovenous fistula or graft vascular access surgery

3. Kidney transplantation planned within 6 months

4. Metastatic malignancies or other condition associated with a life expectancy of <6 months, in the opinion of the attending nephrologist

5. Unable to provide informed consent

6. Dusseux risk score <5, indicating an usually long life expectancy for elderly patients starting hemodialysis treatment (the Dusseux risk score was adapted for patients between 65 and 70 years by assigning -3 points to this age category)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maarten G Snoeijs, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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

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

Countries

Netherlands

Other Identifiers

NL7933

Identifier Type: OTHER

Identifier Source: secondary_id

NL70385.068.19

Identifier Type: -

Identifier Source: org_study_id