The primary objective of this study is to gain more knowledge about the mean and the distribution of mitochondrial oxygen tension (mitoPO2), the mitochondrial oxygen consumption (mitoVO2) and the affinity for oxygen of mitochondrial respiratory…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The mean and standard deviation of mitoPO2 will be calculated in mmHg. The
mitoVO2 and mitoP50 will be determined by a decrease in mitoPO2 after oxygen
supply is blocked to the cells . The mitoPO2 will be recorded before during,
and after a 90 second compression. The mitoVO2 is calculated from the decay of
the mitoPO2 slope. With the Michaelis-Menten equation we can calculate MitoP50
in mmHg.
Secondary outcome
The practical applicability of the method will be tested by the researcher. If
necessary adjustments will be made. The raw data of the measurements will be
stored for extended off-line analysis of the signal quality. If necessary, we
will look at opportunities to optimize the equipment.
The structure of the fluorescent signal, determines by means of the intensity
of the detected signal (V) divided by time (minutes), expressed in V / minute.
The influence of skin temperature to the search parameters (mitoPO2, and
mitoVO2 mitoP50), will be determined at two different skin temperatures (34 and
40 degrees celsius ).
Background summary
Sepsis and septic shock are life-threatening diseases. A early aggressive
treatment of septic patients, by administering intravenous fluids and inotropy
for improving the oxygen supply to the cells leads to a improved survival
outcome. When the same treatment is applied at a later stage of the disease the
treatment shows no improvement, and possibly leads to more damage. That a
adequate tissue perfusion in this later phase does not improves prognosis, may
be explained by a impaired mitochondrial function. Monitoring of these
mitochondrial function has not been possible till to day. The PpIX triplet
state lifetime measurement (PpIX-TSLM) technique, for measurement of
mitochondrial oxygen tension (mitoPO2), oxygen consumption (mitoVO2) and the
the affinity for oxygen to the mitochondrial respiratory chain (mitoP50),
provides a potential means to do so. For the clinical use in human a concept is
developed by using the topically administered 5-aminolevulin. Before this
concept can be successfully developed, it is necessary to gain more knowledge
about the normal values of the parameters measured under physiological
conditions.
Study objective
The primary objective of this study is to gain more knowledge about the mean
and the distribution of mitochondrial oxygen tension (mitoPO2), the
mitochondrial oxygen consumption (mitoVO2) and the affinity for oxygen of
mitochondrial respiratory chain (mitoP50) in the skin. Measured by
cutaneous-PPIX TSLT technique under physiological and resting conditions.
Secondary, we hope to gain a better insight into the signal quality in human
skin and the practical aspects of measurement in humans.
Study design
Observational single centre study pilot study.
Study burden and risks
The PPIX-TSLT technique shows some relationship to the principle of
photodynamic therapy. Possible side effects will resemble the side effects
from this therapy. The expectation is that these will not be occur. Fot that
reason the lightload at the cutaneous-PPIX TSLT is much lower than in
photodynamic therapy. Possible side effects may include: A burning pain during
the measurement itself. And temporary the measurement can give, crusta,
erythema and / or pigmentary changes of the skin afterwards.
Dr. Molewaterplein 50-60
Rotterdam 3015 GE
NL
Dr. Molewaterplein 50-60
Rotterdam 3015 GE
NL
Listed location countries
Age
Inclusion criteria
- Speaking Dutch
- Age between 18 and 30 years.
- Healthy subjects
Exclusion criteria
- Non healthy subjects
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 | NL37911.078.11 |