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ACTIVE NOT RECRUITING
NCT05911451
NA

Optimizing Access Surgery In Senior Hemodialysis Patients

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

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.

Official title: Optimizing Access Surgery In Senior Hemodialysis Patients: a Multicenter Randomized Controlled Trial of Fistulas, Grafts, and Catheters

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2019-11-01

Completion Date

2026-03-31

Last Updated

2025-05-19

Healthy Volunteers

No

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.

Locations (20)

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