The general aim of the current project is to assess the feasibility of two novel monitoring techniques, intradialytic mitoPO2 monitoring and continuous bioimpedance and assess the impact of hemodialysis on mitochondrial level by studying the change…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objectives of this study are to is to describe the effects of the
HD treatment with and without ultrafiltration on the change in mitoPO2 and
mitoVO2.
Secondary outcome
The secondary objectives of this study are to
- Compare pre-dialysis mitoPO2 and mitoVO2 baseline values to the values
obtained in previous studies with the COMET.
- Describe the relation between changes in skin mitoPO2 and mitoVO2 and
intradialytic continuous thoracic bioimpedance.
- Describe the relation between changes in skin mitoPO2 and mitoVO2 and
intradialytic continuous calf bioimpedance.
- Describe the relation between changes in skin mitoPO2 and mitoVO2 and the
change in extracellular resistance ratio measured at the calf
- To evaluate the change in mitoPO2 and bioimpedance prior to and after
intradialytic hypotensive symptoms
- To perform validation of the TBW algorithm from the bioimpedance results by
use of the Body Composition Monitor (BCM)
Secondary study parameters are
- Symptoms of intradialytic hypotension
- Interventions during HD treatment, e.g. positioning in Trendelenburg or
terminating ultrafiltration.
- Total body water from local thoracic bioimpedance measurements
- Total body water from local calf bioimpedance measurements
Background summary
The microcirculation and mitochondrial function at tissue level are altered in
the dialysis population. Dialysis related bioincompatibility, decreased tissue
perfusion and mitochondrial dysfunctions are causes of oxidative stress that
may lead to premature cardiovascular disease (CVD) and aging. Rather than
solely targeting macrocirculatory hemodynamic stability, maintaining an
adequate balance of oxygen supply and demand to the tissue, might form a
relevant target for prevention of organ hypoperfusion and improvement of
cardiovascular outcomes in the hemodialysis population. Intradialytic
monitoring with the Cellular Oxygen METabolism (COMET) that measures
mitochondrial oxygen tension and consumption through the skin would provide
novel information on the direct effect of hemodialysis on mitochondrial level.
Since the mitochondrial oxygen tension is also dependent on the fluid state,
simultaneous bioimpedance measurements would enhance our understanding of the
impact of fluid removal on cellular metabolism.
Study objective
The general aim of the current project is to assess the feasibility of two
novel monitoring techniques, intradialytic mitoPO2 monitoring and continuous
bioimpedance and assess the impact of hemodialysis on mitochondrial level by
studying the change in measured parameters during the hemodialysis treatment.
Study design
This is a prospective observational cohort study in which both intradialytic
mitoPO2 and bioimpedance measurements are conducted during hemodialysis
treatment.
Study burden and risks
The risks in this study are moderate, considered the hemodialysis patient
population is a vulnerable group. Both monitoring devices have been
successfully applied in previous clinical studies with fragile patients, such
as ICU patients. The burden for the hemodialysis patients is minimal since it
concerns non-invasive measurements and the study is solely observational. The
normal clinical practice will continue and will not be altered.
Patients are asked to arrive 20 minutes earlier for their hemodialysis
appointment and to stay 20 minutes longer. On the other hand, patients do not
need to make additional visits to the hospital for this study. Additionally,
they are asked to fill out a short checklist about the symptoms of hypotension
experienced during dialysis and the overall burden of the study.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Age 18 years or higher.
On hemodialysis treatment for at least three months.
Receiving hemodialysis treatment three times a week.
Exclusion criteria
Major limb amputations.
Presence of cardiac implants.
Skin conditions aggravated by sunlight or increased sensitivity to light.
Hypersensitivity to 5-aminolevulinc acid.
Pregnanty or breastfeeding.
Insufficient comprehensibility of the Dutch or English language.
Porphyria.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL87421.058.24 |