Optimizing Access Surgery In Senior Hemodialysis Patients (OASIS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis Access Failure; Arteriovenous Fistula; Vascular Access Complication; Arteriovenous Graft; Dialysis Access Malfunction; Central Venous Catheter Related Bloodstream Infection
• Intervention / Treatment: Procedure: Arteriovenous fistula creation; Procedure: Arteriovenous graft placement; Procedure: Central venous catheter placement

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.

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

• Study Type: Interventional
• Enrollment (Estimated): 195
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maarten G Snoeijs, MD PhD; Phone Number: 0031625097694; Email: maarten.snoeijs@mumc.nl

Study Locations

• Netherlands
  • Alkmaar, Netherlands
    • Recruiting
    • Noordwest Ziekenhuisgroep
    • Contact: Cagdas Unlu, MD PhD
  • Almelo, Netherlands
    • Recruiting
    • Ziekenhuisgroep Twente
    • Contact: Rombout R Kruse, MD PhD
  • Amsterdam, Netherlands
    • Recruiting
    • OLVG
    • Contact: Roos C van Nieuwenhuizen, MD
  • Arnhem, Netherlands
    • Recruiting
    • Rijnstate Ziekenhuis
    • Contact: Jacobien C Verhave, MD PhD
  • Breda, Netherlands
    • Recruiting
    • Amphia Ziekenhuis
    • Contact: Nynke Cnossen, MD PhD
  • Den Haag, Netherlands
    • Recruiting
    • Haaglanden Medisch Centrum
    • Contact: Koen E van der Bogt, MD PhD
  • Dordrecht, Netherlands
    • Recruiting
    • Albert Schweitzer ziekenhuis
    • Contact: Maarten A Lijkwan, MD PhD
  • Eindhoven, Netherlands
    • Recruiting
    • Catharina Ziekenhuis Eindhoven
    • Contact: Philippe W Cuypers, MD PhD
  • Enschede, Netherlands
    • Recruiting
    • Medisch Spectrum Twente
    • Contact: Edith M Willigendael, MD PhD
  • Haarlem, Netherlands
    • Recruiting
    • Spaarne Gasthuis
    • Contact: Denise Nio, MD PhD
  • Heerlen, Netherlands
    • Not yet recruiting
    • Zuyderland Medisch Centrum
    • Contact: Marielle Krekels, MD PhD
  • Leeuwarden, Netherlands
    • Recruiting
    • Medisch Centrum Leeuwarden
    • Contact: Cora H Arts, MD PhD
  • Leiden, Netherlands
    • Recruiting
    • Leids Universitair Medisch Centrum
    • Contact: Joris I Rotmans, MD PhD
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht University Medical Center
    • Contact: Maarten G Snoeijs, MD PhD
  • Nijmegen, Netherlands
    • Recruiting
    • Canisius Wilhelmina Ziekenhuis
    • Contact: Bart Boll, MD PhD
  • Rotterdam, Netherlands
    • Recruiting
    • Franciscus Gasthuis & Vlietland
    • Contact: Gijs M Welten, MD PhD
  • Tilburg, Netherlands
    • Recruiting
    • Elisabeth TweeSteden Ziekenhuis
    • Contact: Patrick W Vriens, MD PhD
  • Veldhoven, Netherlands
    • Recruiting
    • Maxima Medisch Centrum
    • Contact: Bas Govaert, MD PhD
  • Venlo, Netherlands
    • Recruiting
    • VieCuri Medisch Centrum
    • Contact: Jan-Willem Elshof, MD PhD
  • Zwolle, Netherlands
    • Recruiting
    • Isala Klinieken
    • Contact: Marijke Molegraaf, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Maarten G Snoeijs, MD PhD, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Sepsis; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: NL70385.068.19; NL7933 (Other Identifier: Netherlands Trial Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The following end products I will make available for further research and verification:

• Data documentation
• Documentation of the research process, including documentation of all participants
• Audiovisual material / images
• Several versions of processed data
• Raw data

• IPD Sharing Time Frame: The embargo period will be as long as required for publication of the research findings.
• IPD Sharing Access Criteria: Interested parties can submit a request for a data set.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No