Compare succesfull creation and usage of the buttonhole track for hemodialyses, created by either the conventional way or with the supercath
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Compare the effect of buttonhole track creation by either the conventional or
the supercath method on
- succesfull creation buttonhole after development phase ( supercath 10 days-
traditional 12 days)
- succesfull usage buttonhole track during 6 months (scoring number
miscannulations)
Secondary outcome
Compare the effect of buttonhole track creation by either the conventional or
the supercath method on
- skin/shunt infections
- pain perception patient (VAS scores)
- costeffectiveness/ logistics
- required angiografpic inrteventions.
Background summary
An easy accesable av fistula is an essential requirement for hemodialysis.
Unfortunately, frequently there are cannulation problems due to difficult
accessability which results in increased regional cannulation, pain,
miscannulation and fear for many hemodialysis patients. By using a buttonhole,
i.e. a fistula between the skin and the vascular access, most of these problems
disappear. By using a new creation method for the buttonhole with the
supercath , the buttonhole can be created with more ease and in a better way
due to less variation in comparison to the conventional buttonhole.
Study objective
Compare succesfull creation and usage of the buttonhole track for hemodialyses,
created by either the conventional way or with the supercath
Study design
Randomised open intervention study
Intervention
creation buttonhole track by either the conventional or the supercath method.
Study burden and risks
Time consumption:
-During followup the patient is requested to do VAS scoring lists
in total 9 times in 6 months, requiring 5 min-session. This can be done duing
the hemodialysis sesion
-Risks:
The buttonhole creation by the conventional method is known to be associated
with an increased risk for infection during the creation phase in comparison to
regular cannulation without a buttonhole due to the usage of foreign material
i.e. biohole plugs, which are applied after each dialysis session and removed
before the next session. This risk may be higher by using the supercath needles
because these needles remain in situ for 10 days, while used for dialysis and
the creation of the buttonhole cannulation track. Earlier research did not
observe an increased risk for infection with this method. However,to prevent
infection, this researchprotocol uses mupirocin cream applied to the exit
side.
Also there is a very small risk of disconnection of the supercath needle. In
order to prevent this the needle is fixated by sterile plasters. In case this
occurs the patient should act as if it was a regular shuntbleeding. Because of
this small risks the exclusion criteria for this study encompass incapability
to press the fistula and living alone.
Groen Hilledijk 315
3075 ea Rotterdam
NL
Groen Hilledijk 315
3075 ea Rotterdam
NL
Listed location countries
Age
Inclusion criteria
-patient receiving hemodialysis
-recently created AV fistula or existing AV fistula with cannulation problems
Exclusion criteria
-PTFE loop
-shunt depth> 0,8 cm
-physical inability to create pressure on AV fistula during shunt bleeding
-living alone
Design
Recruitment
Medical products/devices used
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 | NL36294.101.11 |