The main objective of this study is to show that the basilic vein transposition in the current elderly population is superior to the brachiocubiti fistula in terms of easy cannulation and maturation. Primary outcome is one year patency We will also…
ID
Source
Brief title
Condition
- Nephropathies
- Vascular therapeutic procedures
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
primary study parameters:
1. is there a difference in primary patency after one year?
Secondary outcome
Secundary study parameters:
1. is there a difference in thrombosis-free interval?
2. is there a difference in the amount of interventions needed?
3. Is there a difference in usability ?
a. duration untill first cannulation
b. total time of non-usability as a result of revision operations
c. easy cannulation
d. time of compression for hemostasis after cannulation
e. complications: infection, thrombosis, aneurysm, haematoma, steal, edema
4. effect of fistula on periferal circulation
Background summary
According to current international standards (NKF K/DOQI guidelines) a
brachiocubiti arteriovenous fistula is second choice for creating hemodialysis
access in patiënts with end stage renal disease (ESRD). The most frequently
used ellbow fistula are the brachiocephalic fistula or the Gracz fistula in
which the perforating vein is used. When using the perforating vein one cannot
predict if the fistula will drain in the superficially located cephalic vein or
in the deeper located basilic vein. Drainage in the deeper basilic vein could
result in a fistula that is difficult or even impossible to cannulate. The
basilic vein is often of good quality because of its deep location. Because of
the deep location transposition to a superficial location is needed to garantee
easy cannulation. We think that in the current elderly dialysis population it
may be that instead of a brachiocubiti fistula a basilic vein transposition is
a better option because of the higher chance of maturation and easyer
cannulation. Even though it implicates a larger wound area and longer operating
time.
Study objective
The main objective of this study is to show that the basilic vein transposition
in the current elderly population is superior to the brachiocubiti fistula in
terms of easy cannulation and maturation. Primary outcome is one year patency
We will also look at the difference in complications and interventions.
Study design
A non-blinded randomized multicenter trial
Intervention
Creation of an arteriovenous fistula for hemodialysis
The intervention will either be Basilic vein transposition or creation of an
ellbow arteriovenous fistula.
Study burden and risks
- follow up will be conform standard protocol after creation of an upperarm
fistula. In addition patients are asked to registrate pain by means of an VAS
painscore pre and postoperative ( 4 times in total).
- as the intervention will be either one of two standard procedures the risks
of participation will not be different from standard treatment. Because the BB
AVF requires a more extensive woundbed there might be a higher level of pain in
that group. This will be documented with the VAS painscore
Kleiweg 500
3045 PM Rotterdam
NL
Kleiweg 500
3045 PM Rotterdam
NL
Listed location countries
Age
Inclusion criteria
-end stage renal failure with need for chronic intermittent hemodialysis
-creation of a forerarm fistula is not feasible, or failure of a forearm graft or fistula.
-diameter of brachial artery, cephalic and basilic upper-arm vein of at least 3.0 mm
Exclusion criteria
-active locoregional or systemic infection
-ischemia of ipsilateral arm
-not being able to understand and/or give 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 | NL23188.101.08 |