Back to resultsOptimizing Access Surgery In Senior Hemodialysis Patients (OASIS)
Primary Purpose
Vascular Access Complication, Hemodialysis Access Failure, Dialysis Access Malfunction
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Arteriovenous fistula creation
Arteriovenous graft placement
Central venous catheter placement
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Access Complication
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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)
Sites / Locations
- Noordwest ZiekenhuisgroepRecruiting
- Ziekenhuisgroep TwenteRecruiting
- OLVGRecruiting
- Rijnstate ZiekenhuisRecruiting
- Amphia ZiekenhuisRecruiting
- Haaglanden Medisch CentrumRecruiting
- Albert Schweitzer ZiekenhuisRecruiting
- Catharina Ziekenhuis EindhovenRecruiting
- Medisch Spectrum TwenteRecruiting
- Spaarne GasthuisRecruiting
- Zuyderland Medisch Centrum
- Medisch Centrum LeeuwardenRecruiting
- Leids Universitair Medisch CentrumRecruiting
- Maastricht University Medical CenterRecruiting
- Canisius Wilhelmina ZiekenhuisRecruiting
- Franciscus Gasthuis & VlietlandRecruiting
- Elisabeth Tweesteden ZiekenhuisRecruiting
- Maxima Medisch CentrumRecruiting
- Viecuri Medisch CentrumRecruiting
- Isala KliniekenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Arteriovenous fistula
Arteriovenous graft
Central venous catheter
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient-reported outcome measures (1)
Short Form 12 Dialysis Symptom Index (SF-12 / DSI)
Patient-reported outcome measures (2)
Short Form Vascular Access Questionnaire (SF-VAQ)
Patient-reported outcome measures (3)
EuroQol - 5 dimensions - 5 levels (EQ-5D-5L)
Health care costs
Medical Consumption Questionnaire
Access-related complications
Access-related complications requiring pharmacological treatment (Clavien-Dindo grade 2)
Days in hospital
The number of days admitted to hospital or visiting out-patient clinics for any reason per person-year (including hemodialysis sessions).
Mortality
All-cause mortality
Primary patency
Outcome measure registered for exploratory analysis
Assisted primary patency
Outcome measure registered for exploratory analysis
Secondary patency
Outcome measure registered for exploratory analysis
Primary functional patency
Outcome measure registered for exploratory analysis
Time until mature vascular access
Outcome measure registered for exploratory analysis
Time until functional vascular access
Outcome measure registered for exploratory analysis
The number of hemodialysis sessions with cannulation difficulties
Outcome measure registered for exploratory analysis
Full Information
NCT ID
NCT05911451
First Posted
May 26, 2023
Last Updated
September 5, 2023
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05911451
Brief Title
Optimizing Access Surgery In Senior Hemodialysis Patients
Acronym
OASIS
Official Title
Optimizing Access Surgery In Senior Hemodialysis Patients: a Multicenter Randomized Controlled Trial of Fistulas, Grafts, and Catheters
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
Data analysis: Poisson regression analysis with time as off-set variable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Access Complication, Hemodialysis Access Failure, Dialysis Access Malfunction, Arteriovenous Fistula, Arteriovenous Graft, Central Venous Catheter Related Bloodstream Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel group, multicenter randomized controlled trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
195 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arteriovenous fistula
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arteriovenous graft
Arm Type
Experimental
Arm Description
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.
Arm Title
Central venous catheter
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arteriovenous fistula creation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arteriovenous graft placement
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Central venous catheter placement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Access-related intervention rate
Description
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.
Time Frame
Variable follow-up time of at least 1 year
Secondary Outcome Measure Information:
Title
Patient-reported outcome measures (1)
Description
Short Form 12 Dialysis Symptom Index (SF-12 / DSI)
Time Frame
Every 3 months in the first year after enrollment and in the first year after dialysis start
Title
Patient-reported outcome measures (2)
Description
Short Form Vascular Access Questionnaire (SF-VAQ)
Time Frame
Every 3 months in the first year after enrollment and in the first year after dialysis start
Title
Patient-reported outcome measures (3)
Description
EuroQol - 5 dimensions - 5 levels (EQ-5D-5L)
Time Frame
Every 3 months in the first year after enrollment and in the first year after dialysis start
Title
Health care costs
Description
Medical Consumption Questionnaire
Time Frame
Every 3 months in the first year after enrollment and in the first year after dialysis start
Title
Access-related complications
Description
Access-related complications requiring pharmacological treatment (Clavien-Dindo grade 2)
Time Frame
Variable follow-up time of at least 1 year
Title
Days in hospital
Description
The number of days admitted to hospital or visiting out-patient clinics for any reason per person-year (including hemodialysis sessions).
Time Frame
Variable follow-up time of at least 1 year
Title
Mortality
Description
All-cause mortality
Time Frame
Variable follow-up time of at least 1 year
Title
Primary patency
Description
Outcome measure registered for exploratory analysis
Time Frame
Variable follow-up time of at least 1 year
Title
Assisted primary patency
Description
Outcome measure registered for exploratory analysis
Time Frame
Variable follow-up time of at least 1 year
Title
Secondary patency
Description
Outcome measure registered for exploratory analysis
Time Frame
Variable follow-up time of at least 1 year
Title
Primary functional patency
Description
Outcome measure registered for exploratory analysis
Time Frame
Variable follow-up time of at least 1 year
Title
Time until mature vascular access
Description
Outcome measure registered for exploratory analysis
Time Frame
Variable follow-up time of at least 1 year
Title
Time until functional vascular access
Description
Outcome measure registered for exploratory analysis
Time Frame
Variable follow-up time of at least 1 year
Title
The number of hemodialysis sessions with cannulation difficulties
Description
Outcome measure registered for exploratory analysis
Time Frame
Variable follow-up time of at least 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maarten G Snoeijs, MD PhD
Phone
0031625097694
Email
maarten.snoeijs@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten G Snoeijs, MD PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Noordwest Ziekenhuisgroep
City
Alkmaar
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cagdas Unlu, MD PhD
Facility Name
Ziekenhuisgroep Twente
City
Almelo
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rombout R Kruse, MD PhD
Facility Name
OLVG
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roos C van Nieuwenhuizen, MD
Facility Name
Rijnstate Ziekenhuis
City
Arnhem
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacobien C Verhave, MD PhD
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nynke Cnossen, MD PhD
Facility Name
Haaglanden Medisch Centrum
City
Den Haag
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen E van der Bogt, MD PhD
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maarten A Lijkwan, MD PhD
Facility Name
Catharina Ziekenhuis Eindhoven
City
Eindhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe W Cuypers, MD PhD
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edith M Willigendael, MD PhD
Facility Name
Spaarne Gasthuis
City
Haarlem
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Nio, MD PhD
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marielle Krekels, MD PhD
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cora H Arts, MD PhD
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joris I Rotmans, MD PhD
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maarten G Snoeijs, MD PhD
Facility Name
Canisius Wilhelmina Ziekenhuis
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bart Boll, MD PhD
Facility Name
Franciscus Gasthuis & Vlietland
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gijs M Welten, MD PhD
Facility Name
Elisabeth Tweesteden Ziekenhuis
City
Tilburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick W Vriens, MD PhD
Facility Name
Maxima Medisch Centrum
City
Veldhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bas Govaert, MD PhD
Facility Name
Viecuri Medisch Centrum
City
Venlo
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan-Willem Elshof, MD PhD
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marijke Molegraaf, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Optimizing Access Surgery In Senior Hemodialysis Patients
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