The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of an anatomical or hemodynamic significant stenosis in patients with a brachiocephalic or radiocephalic AVF.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Duplex Ultrasonography ± 6 weeks postoperative: prevalence of anatomical or
hemodynamic significant stenosis and the area of the stenosis in the arterial
inflow, anastomosis or venous outflow region. - significant anatomical
stenosis: a decrease >50% of vessel diameter compared to the immediately
upstream or downstream 'normal' vessel - significant hemodynamically arterial
inflow or venous outflow stenosis: Peak Systolic Velocity Ratio 2 or greater. -
significant hemodynamically anastomotic stenosis: Peak Systolic Velocity Ratio
3 or greater.
Secondary outcome
To compare preoperative factors between groups: - Demographic characteristics:
age, gender, length, weight, BMI, smoking, use of drugs or alcohol, dominant
arm, race. - Co-morbidity: indication AVF, Diabetes Mellitus, hypertension,
hypercholesterolemy, peripheral arterial disease, etc. - Use of medication -
Laboratory results. To compare operative factors between groups: - Duration of
operation, duration of bloodless surgery, complications. To compare
postoperative outcomes between groups: - Complications: death, hematoma,
stenosis, occlusion, decrease of flow, bleeding, infection, pseudoaneurysm,
accessory veins, steal syndrome, non-maturation, cardiac en pulmonary
complications, reintervention. - Primary patency - Secondary patency
Background summary
Patients with a chronic kidney disease who opt for hemodialysis, needs a
well-functioning hemodialysis access. The autologous arteriovenous fistula
(AVF) is recognized as the golden standard of dialysis access(1). Unfortunately
a great number of the AVFs fail to mature, and therefore cannot be used for
dialysis. A significant stenosis is a major cause of nonmaturing AVFs (2,3).
Remarkable are the stenoses that seem to develop in the venous outflow tract
where the vascular clamp was located during surgery. The primary aim of this
study was to compare bloodless surgery using vascular clamps and a tourniquet
with respect to the development of hemodynamic or anatomical significant
stenosis in patients with a brachiocephalic or radiocephalic AVF.
Study objective
The primary aim of this study was to compare bloodless surgery using vascular
clamps and a tourniquet with respect to the development of an anatomical or
hemodynamic significant stenosis in patients with a brachiocephalic or
radiocephalic AVF.
Study design
A randomized controlled trial. Patients will be randomized to the use of a
tourniquet or vascular clamps to obtain a bloodless field during arteriovenous
fistula surgery. An interim analysis will be done after the inclusion of 52
patients.
Intervention
Intervention: the use of a tourniquet to obtain a bloodless field during
arteriovenous fistula surgery. Comparator: the use of vascular clamps to obtain
a bloodless field during arteriovenous fistula surgery.
Study burden and risks
Patients will, except the informed consent procedure, not undergo extra exams
for study purposes.
Leyweg 275
Den Haag 2545CH
NL
Leyweg 275
Den Haag 2545CH
NL
Listed location countries
Age
Inclusion criteria
- Mentally competent
- Written informed consent
- Age 18 years and older
- Indication for brachiocephalic AVF in HagaZiekenhuis
- Patient is able to complete the follow-up evaluation
Exclusion criteria
Pregnancy
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL54827.098.15 |