Optimizing Access Surgery In Senior Hemodialysis Patients

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

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

Interventions

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.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Maarten G Snoeijs, MD PhD · Maastricht University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-01

Primary Completion

2026-03-31

Completion

2026-03-31

Countries

• Netherlands

Study Locations