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Flow Dysfunction of Hemodialysis Vascular Access (FLOW)

Primary Purpose

Dialysis Access Malfunction, Hemodialysis Access Failure, Hemodialysis Fistula Thrombosis

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Vascular access monitoring
Vascular access blood flow measurement
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dialysis Access Malfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients aged 18 years or older. End-stage renal disease with unlikely recovery of kidney function according to the attending nephrologist. Arteriovenous fistula or arteriovenous graft as hemodialysis vascular access that fulfills both of the following criteria at the time of trial enrollment: Vascular access flow volume of at least 500mL/min; and Functional vascular access: the vascular access was cannulated with 2 needles and achieved the prescribed access circuit flow in at least 6 dialysis sessions over the past 30 days. Patients who have single needle hemodialysis for reasons other than vascular access dysfunction (e.g. for nocturnal hemodialysis) but who can be cannulated with 2 needles for flow measurements and fulfill the other requirements for a functional vascular access can be enrolled as well. Planning to remain in one of the participating dialysis centers for at least 1 year. Exclusion Criteria: Arteriovenous fistulas with multiple venous outflow paths upstream of the cannulation sites, that are not suitable for flow volume measurements using ultrasound dilution (e.g. Gracz fistulas and Ellipsys or WavelinQ endovascular fistulas). Home hemodialysis. Thrombosis of the current vascular access in the past year. Planned access-related intervention. Living donor kidney transplantation, switch to peritoneal dialysis, or switch to home hemodialysis planned within 6 months. Life expectancy of less than 6 months, in the opinion of the attending nephrologist. Unable to provide informed consent.

Sites / Locations

  • Diapriva - Dialyse Centrum AmsterdamRecruiting
  • OLVGRecruiting
  • Deventer ZiekenhuisRecruiting
  • Medisch Spectrum TwenteRecruiting
  • Spaarne GasthuisRecruiting
  • Zuyderland Medisch CentrumRecruiting
  • Leids Universitair Medisch CentrumRecruiting
  • Maastricht UMC+Recruiting
  • Bravis ZiekenhuisRecruiting
  • Franciscus Gasthuis & Vlietland
  • Universitair Medisch Centrum Utrecht
  • Maxima Medisch CentrumRecruiting
  • Isala KliniekenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

Patients are referred for correction of the underlying stenosis when clinical signs of flow dysfunction are present. These include physical signs, problems during dialysis, or an unexplained, sustained fall in dialysis adequacy.

Monthly surveillance of vascular access blood flow volume by ultrasound dilution measurements during hemodialysis sessions. Patients will be referred for correction of the underlying stenosis at an access flow volume <500mL/min, or when clinical signs of flow dysfunction are present.

Outcomes

Primary Outcome Measures

Access-related intervention rate
The number of interventions required for each patient-year of hemodialysis treatment

Secondary Outcome Measures

Access-related complications per patient-year (1)
Clavien-Dindo grade 2 complications (requiring pharmacological treatment)
Access-related complications per patient-year (2)
Access-related serious adverse events (Clavien-Dindo grade 4 and 5 complications, and vascular access thrombosis)
All-cause mortality
All-cause mortality
Access-related health care costs (1)
Medical Consumption Questionnaire
Access-related health care costs (2)
Productivity Cost Questionnaire
Patient-reported outcome measures (1)
SF-VAQ (Short-Form Vascular Access Questionnaire)
Patient-reported outcome measures (2)
EQ-5D-5L
Quality of the surveillance program (1)
Repeatability and reproducibility of vascular access flow volume measurements
Quality of the surveillance program (2)
Diagnostic accuracy of vascular access flow volume measurements to predict clinical signs of flow dysfunction and access thrombosis within 1 month in the intervention group
Quality of the surveillance program (3)
The percentage of vascular access balloon angioplasties resulting in technical success (residual stenosis <30%) and clinical success (increase in flow volume to >500mL/min, restoration of vascular access function and resolution of any clinical signs of flow dysfunction)
Quality of the surveillance program (4)
Vascular access patency after balloon angioplasty
Primary patency
This outcome measure will be registered for explanatory analyses
Assisted primary patency
This outcome measure will be registered for explanatory analyses
Secondary patency
This outcome measure will be registered for explanatory analyses
The number of hemodialysis sessions with cannulation difficulties
This outcome measure will be registered for explanatory analyses

Full Information

First Posted
May 23, 2023
Last Updated
June 13, 2023
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05906550
Brief Title
Flow Dysfunction of Hemodialysis Vascular Access
Acronym
FLOW
Official Title
Flow Dysfunction of Hemodialysis Vascular Access: a Randomized Controlled Trial on the Effectiveness of Surveillance of Arteriovenous Fistulas and Grafts
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 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 FLOW trial evaluates the follow-up of the vascular access for hemodialysis. In current clinical care, vascular access flow volume is periodically assessed to detect and treat asymptomatic stenosis. The FLOW trial will determine whether it is safe to abandon this practice of active surveillance. Vascular access stenosis will then be treated only when clinical problems of flow dysfunction occur during hemodialysis. The investigators expect that the intervention rate and medical costs will be reduced by 40% when correction of vascular access stenosis is triggered by clinically apparent access dysfunction rather than asymptomatic flow reduction.
Detailed Description
Study design: Multicenter randomized controlled trial with 417 patients. Patients will be followed up for 2 to 3 years. The trial is powered to detect a reduction in the intervention rate of 0.25 per year between study groups in a superiority analysis (this is associated with cost savings of 1 million euros per year in the Netherlands). Subgroup analyses of arteriovenous fistulas and grafts and of successful and failed interventions will be done. Study population: Chronic hemodialysis patients with a functioning arteriovenous fistula or graft. Intervention group: Patients are referred for correction of the underlying stenosis when clinical signs of flow dysfunction are present. These include physical signs, problems during dialysis, or an unexplained, sustained fall in dialysis adequacy. Control group: Monthly surveillance of vascular access blood flow volume by ultrasound dilution measurements during hemodialysis sessions. Patients will be referred for correction of the underlying stenosis at an access flow volume <500mL/min, or when clinical signs of flow dysfunction are present.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dialysis Access Malfunction, Hemodialysis Access Failure, Hemodialysis Fistula Thrombosis, Vascular Access Malfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized controlled trial with hybrid parallel-crossover design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The software of the HD03 Hemodialysis Monitor will be adjusted to allow blinded measurements that will be sent to the trial coordinator; patients and health care providers remain unaware of treatment allocation and surveillance findings. Flow measurements will only be used to refer patients for correction of vascular access stenosis in the control group. To maintain blinding, whenever a measurement must be repeated to confirm low flow volumes, another trial participant will randomly be selected for confirmation of vascular access flow volumes after the next measurement. Patients will be censored and randomized anew following an intervention for flow dysfunction, as soon as the indicator for vascular access intervention has been resolved and vascular access function has been restored.
Allocation
Randomized
Enrollment
417 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Patients are referred for correction of the underlying stenosis when clinical signs of flow dysfunction are present. These include physical signs, problems during dialysis, or an unexplained, sustained fall in dialysis adequacy.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Monthly surveillance of vascular access blood flow volume by ultrasound dilution measurements during hemodialysis sessions. Patients will be referred for correction of the underlying stenosis at an access flow volume <500mL/min, or when clinical signs of flow dysfunction are present.
Intervention Type
Diagnostic Test
Intervention Name(s)
Vascular access monitoring
Intervention Description
Patients are referred for correction of the underlying stenosis when clinical signs of flow dysfunction are present. These include physical signs, problems during dialysis, or an unexplained, sustained fall in dialysis adequacy. Patients will be referred for correction of the underlying stenosis when clinical signs of flow dysfunction are present.
Intervention Type
Diagnostic Test
Intervention Name(s)
Vascular access blood flow measurement
Intervention Description
Monthly surveillance of vascular access blood flow volume by ultrasound dilution measurements during hemodialysis sessions. Patients will be referred for correction of the underlying stenosis at an access flow volume <500mL/min.
Primary Outcome Measure Information:
Title
Access-related intervention rate
Description
The number of interventions required for each patient-year of hemodialysis treatment
Time Frame
Variable follow-up time of 2-3 years
Secondary Outcome Measure Information:
Title
Access-related complications per patient-year (1)
Description
Clavien-Dindo grade 2 complications (requiring pharmacological treatment)
Time Frame
Variable follow-up time of 2-3 years
Title
Access-related complications per patient-year (2)
Description
Access-related serious adverse events (Clavien-Dindo grade 4 and 5 complications, and vascular access thrombosis)
Time Frame
Variable follow-up time of 2-3 years
Title
All-cause mortality
Description
All-cause mortality
Time Frame
Variable follow-up time of 2-3 years
Title
Access-related health care costs (1)
Description
Medical Consumption Questionnaire
Time Frame
Every 3 months for 2-3 years from randomization (variable follow-up time)
Title
Access-related health care costs (2)
Description
Productivity Cost Questionnaire
Time Frame
Every 3 months for 2-3 years from randomization (variable follow-up time)
Title
Patient-reported outcome measures (1)
Description
SF-VAQ (Short-Form Vascular Access Questionnaire)
Time Frame
Every 3 months for 2-3 years from randomization (variable follow-up time)
Title
Patient-reported outcome measures (2)
Description
EQ-5D-5L
Time Frame
Every 3 months for 2-3 years from randomization (variable follow-up time)
Title
Quality of the surveillance program (1)
Description
Repeatability and reproducibility of vascular access flow volume measurements
Time Frame
Variable follow-up time of 2-3 years
Title
Quality of the surveillance program (2)
Description
Diagnostic accuracy of vascular access flow volume measurements to predict clinical signs of flow dysfunction and access thrombosis within 1 month in the intervention group
Time Frame
Variable follow-up time of 2-3 years
Title
Quality of the surveillance program (3)
Description
The percentage of vascular access balloon angioplasties resulting in technical success (residual stenosis <30%) and clinical success (increase in flow volume to >500mL/min, restoration of vascular access function and resolution of any clinical signs of flow dysfunction)
Time Frame
Variable follow-up time of 2-3 years
Title
Quality of the surveillance program (4)
Description
Vascular access patency after balloon angioplasty
Time Frame
Variable follow-up time of 2-3 years
Title
Primary patency
Description
This outcome measure will be registered for explanatory analyses
Time Frame
Variable follow-up time of 2-3 years
Title
Assisted primary patency
Description
This outcome measure will be registered for explanatory analyses
Time Frame
Variable follow-up time of 2-3 years
Title
Secondary patency
Description
This outcome measure will be registered for explanatory analyses
Time Frame
Variable follow-up time of 2-3 years
Title
The number of hemodialysis sessions with cannulation difficulties
Description
This outcome measure will be registered for explanatory analyses
Time Frame
Variable follow-up time of 2-3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients aged 18 years or older. End-stage renal disease with unlikely recovery of kidney function according to the attending nephrologist. Arteriovenous fistula or arteriovenous graft as hemodialysis vascular access that fulfills both of the following criteria at the time of trial enrollment: Vascular access flow volume of at least 500mL/min; and Functional vascular access: the vascular access was cannulated with 2 needles and achieved the prescribed access circuit flow in at least 6 dialysis sessions over the past 30 days. Patients who have single needle hemodialysis for reasons other than vascular access dysfunction (e.g. for nocturnal hemodialysis) but who can be cannulated with 2 needles for flow measurements and fulfill the other requirements for a functional vascular access can be enrolled as well. Planning to remain in one of the participating dialysis centers for at least 1 year. Exclusion Criteria: Arteriovenous fistulas with multiple venous outflow paths upstream of the cannulation sites, that are not suitable for flow volume measurements using ultrasound dilution (e.g. Gracz fistulas and Ellipsys or WavelinQ endovascular fistulas). Home hemodialysis. Thrombosis of the current vascular access in the past year. Planned access-related intervention. Living donor kidney transplantation, switch to peritoneal dialysis, or switch to home hemodialysis planned within 6 months. Life expectancy of less than 6 months, in the opinion of the attending nephrologist. Unable to provide informed consent.
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
Diapriva - Dialyse Centrum Amsterdam
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janneke A Rood, MD PhD
Facility Name
OLVG
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl E Siegert, MD PhD
Facility Name
Deventer Ziekenhuis
City
Deventer
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daan J de Boer, MD
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels Brinkman, MD
Facility Name
Spaarne Gasthuis
City
Haarlem
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joost W van der Heijden, MD
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Stifft, 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 UMC+
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maarten G Snoeijs, MD PhD
Facility Name
Bravis Ziekenhuis
City
Roosendaal
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Bunthof, MD
Facility Name
Franciscus Gasthuis & Vlietland
City
Rotterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joep van der Leeuw, MD PhD
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine C Meijvis, MD PhD
Facility Name
Maxima Medisch Centrum
City
Veldhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sander W Keet, MD PhD
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Femke Waanders, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The size of the data collection is unknown but includes physical examination forms, Transonic flow measurement curves, angiography videos, and intervention notes. The following end products will be made 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

Flow Dysfunction of Hemodialysis Vascular Access

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