Optimizing Access Surgery In Senior Hemodialysis Patients

Arteriovenous Fistula Clinical Trial

— OASIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911451
• Other study ID #: NL70385.068.19
• Secondary ID: NL7933
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: May 1, 2025

Study information

• Verified date: September 2023
• Source: Maastricht University Medical Center
• Contact: Maarten G Snoeijs, MD PhD
• Phone: 0031625097694
• Email: maarten.snoeijs[@]mumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Data analysis: Poisson regression analysis with time as off-set variable.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	OLVG	Amsterdam
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Haaglanden Medisch Centrum	Den Haag
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	Elisabeth Tweesteden Ziekenhuis	Tilburg
Netherlands	Maxima Medisch Centrum	Veldhoven
Netherlands	Viecuri Medisch Centrum	Venlo
Netherlands	Isala Klinieken	Zwolle

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Patient-reported outcome measures (2)	Short Form Vascular Access Questionnaire (SF-VAQ)	Every 3 months in the first year after enrollment and in the first year after dialysis start
Secondary	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
Secondary	Health care costs	Medical Consumption Questionnaire	Every 3 months in the first year after enrollment and in the first year after dialysis start
Secondary	Access-related complications	Access-related complications requiring pharmacological treatment (Clavien-Dindo grade 2)	Variable follow-up time of at least 1 year
Secondary	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
Secondary	Mortality	All-cause mortality	Variable follow-up time of at least 1 year
Secondary	Primary patency	Outcome measure registered for exploratory analysis	Variable follow-up time of at least 1 year
Secondary	Assisted primary patency	Outcome measure registered for exploratory analysis	Variable follow-up time of at least 1 year
Secondary	Secondary patency	Outcome measure registered for exploratory analysis	Variable follow-up time of at least 1 year
Secondary	Primary functional patency	Outcome measure registered for exploratory analysis	Variable follow-up time of at least 1 year
Secondary	Time until mature vascular access	Outcome measure registered for exploratory analysis	Variable follow-up time of at least 1 year
Secondary	Time until functional vascular access	Outcome measure registered for exploratory analysis	Variable follow-up time of at least 1 year
Secondary	The number of hemodialysis sessions with cannulation difficulties	Outcome measure registered for exploratory analysis	Variable follow-up time of at least 1 year