Optimizing Access Surgery In Senior Hemodialysis Patients

NCT05911451 | Completed DMC

• 2 other identifiers: NL70385.068.19NL7933
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 20

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Patient-reported outcome measures (1)

  Every 3 months in the first year after enrollment and in the first year after dialysis start

• Patient-reported outcome measures (2)

  Every 3 months in the first year after enrollment and in the first year after dialysis start

• Patient-reported outcome measures (3)

  Every 3 months in the first year after enrollment and in the first year after dialysis start

• Health care costs

  Every 3 months in the first year after enrollment and in the first year after dialysis start

• Access-related complications

  Variable follow-up time of at least 1 year

Study Arms (3)

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.

Procedure: Arteriovenous fistula creation

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.

Procedure: Arteriovenous graft placement

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.

Procedure: Central venous catheter placement

Interventions

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.

Arteriovenous fistula

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.

Arteriovenous graft

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.

Central venous catheter

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Adult patients aged 65 years or older
• End-stage renal disease with unlikely recovery of kidney function according to the attending nephrologist
• Hemodialysis is the intended long-term modality of treatment for end-stage renal disease
• 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
• \. 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.

You may not qualify if:

• Patent arteriovenous fistula or graft already in place
• Prior unsuccessful arteriovenous fistula or graft vascular access surgery
• Kidney transplantation planned within 6 months
• Metastatic malignancies or other condition associated with a life expectancy of \<6 months, in the opinion of the attending nephrologist
• Unable to provide informed consent
• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (20)

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Location

Ziekenhuisgroep Twente

Almelo, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

Rijnstate Ziekenhuis

Arnhem, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Location

Catharina Ziekenhuis Eindhoven

Eindhoven, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Spaarne Gasthuis

Haarlem, Netherlands

Location

Zuyderland Medisch Centrum

Heerlen, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

Franciscus Gasthuis & Vlietland

Rotterdam, Netherlands

Location

Haaglanden Medisch Centrum

The Hague, Netherlands

Location

Elisabeth Tweesteden Ziekenhuis

Tilburg, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, Netherlands

Location

Viecuri Medisch Centrum

Venlo, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Central Venous Catheters

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vascular Access Devices; Catheters; Equipment and Supplies

Study Officials

• Maarten G Snoeijs, MD PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Parallel group, multicenter randomized controlled trial.

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 22, 2023
• Study Start: November 1, 2019
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: The embargo period will be as long as required for publication of the research findings.
• Access Criteria: Interested parties can submit a request for a data set.

Locations

NL (20)