See above.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the access-related intervention rate.
Secondary outcome
Secondary outcome measures are complications, medical and societal costs,
patient-reported outcomes, and the quality of the surveillance program.
Background summary
The FLOW project 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
project 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. We expect that the
intervention rate and medical costs will be reduced by 40% (3.0 million euros
per year) when correction of vascular access stenosis is triggered by
clinically apparent access dysfunction rather than asymptomatic flow reduction.
Study objective
See above.
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). Subgroup analyses of arteriovenous
fistulas and grafts and of successful and failed interventions will be done.
Intervention
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.
Study burden and risks
Patients randomised to the intervention group may have an increased incidence
of vascular access thrombosis. On the other hand, patients randomised to the
control group may undergo unnecessary interventions for vascular access
stenosis. Study participants will have to fill in questionnaires, which will
take approximately 8 hours over the course of the trial.
P. Debyeplein 25
Maastricht 6202AZ
NL
P. Debyeplein 25
Maastricht 6202AZ
NL
Listed location countries
Age
Inclusion criteria
1. Adult patients aged 18 years or older.
2. End-stage renal disease with unlikely recovery of kidney function according
to the attending nephrologist.
3. Arteriovenous fistula or arteriovenous graft as hemodialysis vascular access
that fulfills both of the following criteria at the time of trial enrollment:
a. Vascular access flow volume of at least 500mL/min; and
b. 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.
4. Planning to remain in one of the participating dialysis centers for at least
1 year.
Exclusion criteria
1. 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).
2. Home hemodialysis.
3. Thrombosis of the current vascular access in the past year.
4. Planned access-related intervention.
5. Living donor kidney transplantation, switch to peritoneal dialysis, or
switch to home hemodialysis planned within 6 months.
6. Life expectancy of less than 6 months, in the opinion of the attending
nephrologist.
7. Unable to provide informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75845.068.20 |
| Other | NL9165 |