Primary objective* To investigate the correlation between cutaneous microcirculation (using LSCI), finger and toe pressures and shunt flow in hemodialysis patients.Secondary objectives* To investigate the variability in basal flow measured with LSCI…
ID
Source
Brief title
Condition
- Nephropathies
- Vascular therapeutic procedures
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* correlation of finger and toe pressures with LSCI and shuntflow measurements
Secondary outcome
* Variability of microcirculation measured with LSCI in hemodialysis patients.
* Association between shuntflow and basal blood flow measured with
microcirculation measurements using LSCI
* * LSCI (blood flow upon occlusion/reperfusion) and shunt flow
* Effect of a hemodialysis session on finger and toe pressures and LSCI basal
blood flow
* Correlation between blood flow upon occlusion/reperfusion ( endothelial
function) using LSCI in hemodialysis patients and retrospective good/poor AVF
maturation.
Background summary
Arteriovenous fistulas (AVF*s) or arteriovenous grafts (AVG*s) are used
commonly as vascular access for maintenance hemodialysis. From retrospective
series, case series and animal studies it is known that the creation of a AVF
or AVG results in a certain systemic steal and compromise cardiac function.
However, it is yet unknown in what extend this is and if there are any risk
factors to develop systemic steal and subsequent cardiac problems. Therefore,
the aim of the present study is to get more insight in the influence of
hemodialysis and the creation of an AVF or AVG on systemic (micro) circulation.
Additionally endothelial dysfunction, and therefore probably microcirculation,
plays a role in failure to mature in AVF surgery. A recent study show that
microcirculation measured with infrared thermal imaging (FLIR) can predict
maturation in AVF surgery.
This study will be used to measure the variability in microcirculation measured
with LSCI in hemodialysis patients. This validation study is performed as
preparation of a future study in which we want to measure pre- and
postoperative micro-circulation prospectively in patients that undergo vascular
access surgery, to investigate the influence of an AVF/ AVG on
micro-circulation, and secondly if in the future LSCI could be used as a
predictor for AVF maturation.
In conclusion this study is a validation study of LSCI micro-circulation
measurements in hemodialysis patients and can be used for a future power
calculation for our planned prospective study.
Study objective
Primary objective
* To investigate the correlation between cutaneous microcirculation (using
LSCI), finger and toe pressures and shunt flow in hemodialysis patients.
Secondary objectives
* To investigate the variability in basal flow measured with LSCI in
hemodialysis patients
* To investigate the variability in * LSCI (using occlusion/reperfusion
measurements) in hemodialysis patients
* To investigate if microcirculation with occlusion/reperfusion measurements
(expressing endothelial function) measured with LSCI in hemodialysis patients
is correlated to good/poor AVF maturation (using retrospective data)
Study design
Open observational multicentre study
Study burden and risks
This is an observational study without pharmacological or surgical
intervention. The primary assessments that the study participants will undergo
are measurement of standard vital parameters, finger and toe pressure
measurements and vascular function measurements by LSCI, with
temporary occlusion (of the brachial artery or index finger). These are
non-invasive methods, commonly applied in human studies on vascular
functionality, with a negligible risk for the study participants.
Occlusion/reperfusion measurement will only be performed on the contralateral (
non-shunt) arm.
Lijnbaan 32
Den Haag 2512 VA
NL
Lijnbaan 32
Den Haag 2512 VA
NL
Listed location countries
Age
Inclusion criteria
All subjects must be able to participate and be willing to give written informed consent and to comply with the study restrictions. In addition, eligible subjects must meet the following inclusion criteria:;- Patients male/female > 18 years old that are on hemodialysis using an arteriovenous fistula (AVF) or arteriovenous graft ( AVG) and are capable of giving written informed consent.
Exclusion criteria
1. Concomitant disease or condition that could interfere with the conduct of the study or the study objectives, or that would, in the opinion of the investigator, pose an unacceptable risk to the study participant.
2. Condition of the skin that prohibits accurate LSCI measurements, such as large tattoos, skin ulcers, scar tissue, etc.
3. For group 2: prior vascular access surgery on contra or ipsilateral arm.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64651.098.18 |