Vascular Access ComplicationOASISNCT05911451
Optimizing Access Surgery In Senior Hemodialysis Patients
A study testing Arteriovenous fistula creation, Arteriovenous graft placement and Central venous catheter placement in people with Vascular Access Complication and Hemodialysis Access Failure, run by Maastricht University Medical Center at 20 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vascular Access Complication, Hemodialysis Access Failure, Dialysis Access Malfunction
- What is being tested?
- Arteriovenous fistula creation, Arteriovenous graft placement and Central venous catheter placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 20 sitesNetherlands
- Study dates
- 1 Nov 2019to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
- 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.
Who cannot join
- 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)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Netherlands20 sites
Noordwest Ziekenhuisgroep
Alkmaar
Ziekenhuisgroep Twente
Almelo
OLVG
Amsterdam
Rijnstate Ziekenhuis
Arnhem
Amphia Ziekenhuis
Breda
Albert Schweitzer Ziekenhuis
Dordrecht
Catharina Ziekenhuis Eindhoven
Eindhoven
Medisch Spectrum Twente
Enschede
Spaarne Gasthuis
Haarlem
Zuyderland Medisch Centrum
Heerlen
Medisch Centrum Leeuwarden
Leeuwarden
Leids Universitair Medisch Centrum
Leiden
Maastricht University Medical Center
Maastricht
Canisius Wilhelmina Ziekenhuis
Nijmegen
Franciscus Gasthuis & Vlietland
Rotterdam
Haaglanden Medisch Centrum
The Hague
Elisabeth Tweesteden Ziekenhuis
Tilburg
Maxima Medisch Centrum
Veldhoven
Viecuri Medisch Centrum
Venlo
Isala Klinieken
Zwolle
About this study
Official title: 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.
Read the 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:
- Autologous arteriovenous fistula creation
- Arteriovenous graft implantation
- 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. Due to slow enrollment, follow-up time per participant was much longer than anticipated at trial initiation. After enrollment of 166 participants, calculations based on actual event and mortality rates showed that the trial had sufficient statistical power to detect a relative difference in event rate of 0.67, corresponding to an absolute difference below the minimal clinically relevant difference of 0.80 access-related interventions per year. Therefore, enrollment was closed at 166 participants.
Data analysis: Poisson regression analysis with time as off-set variable.
- Conditions
- Vascular Access Complication, Hemodialysis Access Failure, Dialysis Access Malfunction, Arteriovenous Fistula, Arteriovenous Graft, Central Venous Catheter Related Bloodstream Infection
- Being tested
- Arteriovenous fistula creation, Arteriovenous graft placement, Central venous catheter placement
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arteriovenous fistula creationProcedure or surgery
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 placementProcedure or surgery
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 placementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Central venous catheter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Variable follow-up time of at least 1 year
Secondary outcomes (14)
Patient-reported outcome measures (1)
Short Form 12 Dialysis Symptom Index (SF-12 / DSI)
Measured: 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)
Measured: 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)
Measured: Every 3 months in the first year after enrollment and in the first year after dialysis start
Health care costs
Medical Consumption Questionnaire
Measured: 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)
Measured: 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).
Measured: Variable follow-up time of at least 1 year
Mortality
All-cause mortality
Measured: Variable follow-up time of at least 1 year
Primary patency
Outcome measure registered for exploratory analysis
Measured: Variable follow-up time of at least 1 year
Assisted primary patency
Outcome measure registered for exploratory analysis
Measured: Variable follow-up time of at least 1 year
Secondary patency
Outcome measure registered for exploratory analysis
Measured: Variable follow-up time of at least 1 year
Primary functional patency
Outcome measure registered for exploratory analysis
Measured: Variable follow-up time of at least 1 year
Time until mature vascular access
Outcome measure registered for exploratory analysis
Measured: Variable follow-up time of at least 1 year
Time until functional vascular access
Outcome measure registered for exploratory analysis
Measured: Variable follow-up time of at least 1 year
The number of hemodialysis sessions with cannulation difficulties
Outcome measure registered for exploratory analysis
Measured: Variable follow-up time of at least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Nov 2019
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, multicenter randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Maarten G Snoeijs, MD PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911451
- Sponsor's protocol ID
- NL70385.068.19
- Other IDs
- NL7933
- Acronym
- OASIS
- Status last verified
- Aug 2026
- First submitted
- 26 May 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Access Surgery In Senior Hemodialysis Patients: a Multicenter Randomized Controlled Trial of Fistulas, Grafts, and Catheters
- ClinicalTrials.gov ID
- NCT05911451
- Acronym / sponsor ID
- OASIS / NL70385.068.19
- Conditions
- Vascular Access Complication, Hemodialysis Access Failure, Dialysis Access Malfunction, Arteriovenous Fistula, Arteriovenous Graft, Central Venous Catheter Related Bloodstream Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Autologous arteriovenous fistula creation
- Arteriovenous graft implantation
- 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. Due to slow enrollment, follow-up time per participant was much longer than anticipated at trial initiation. After enrollment of 166 participants, calculations based on actual event and mortality rates showed that the trial had sufficient statistical power to detect a relative difference in event rate of 0.67, corresponding to an absolute difference below the minimal clinically relevant difference of 0.80 access-related interventions per year. Therefore, enrollment was closed at 166 participants.
Data analysis: Poisson regression analysis with time as off-set variable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel group, multicenter randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Arteriovenous fistula | Active comparator | Procedure: Arteriovenous fistula creationPatients 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. |
| Arteriovenous graft | Experimental | Procedure: Arteriovenous graft placementPatients 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. |
| Central venous catheter | Experimental | Procedure: Central venous catheter placementPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arteriovenous fistula creationIt 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 or surgery | Arteriovenous fistula |
| Arteriovenous graft placementIt 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 or surgery | Arteriovenous graft |
| Central venous catheter placementIt 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. | Procedure or surgery | Central venous catheter |
Primary outcome
Access-related intervention rate
Time frame: Variable follow-up time of at least 1 year
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.
14 secondary outcomes
Patient-reported outcome measures (1)
Time frame: Every 3 months in the first year after enrollment and in the first year after dialysis start
Patient-reported outcome measures (2)
Time frame: Every 3 months in the first year after enrollment and in the first year after dialysis start
Patient-reported outcome measures (3)
Time frame: Every 3 months in the first year after enrollment and in the first year after dialysis start
Health care costs
Time frame: Every 3 months in the first year after enrollment and in the first year after dialysis start
Access-related complications
Time frame: Variable follow-up time of at least 1 year
Days in hospital
Time frame: Variable follow-up time of at least 1 year
Mortality
Time frame: Variable follow-up time of at least 1 year
Primary patency
Time frame: Variable follow-up time of at least 1 year
Assisted primary patency
Time frame: Variable follow-up time of at least 1 year
Secondary patency
Time frame: Variable follow-up time of at least 1 year
Primary functional patency
Time frame: Variable follow-up time of at least 1 year
Time until mature vascular access
Time frame: Variable follow-up time of at least 1 year
Time until functional vascular access
Time frame: Variable follow-up time of at least 1 year
The number of hemodialysis sessions with cannulation difficulties
Time frame: Variable follow-up time of at least 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten G Snoeijs, MD PhD principal investigator
Maastricht University Medical Center
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arteriovenous fistula creation, Arteriovenous graft placement and Central venous catheter placement in people with Vascular Access Complication and Hemodialysis Access Failure, run by Maastricht University Medical Center at 20 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access-related intervention rate (time frame: Variable follow-up time of at least 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.