Primary objectives: - To test the hypothesis that a relationship between mitochondrial oxygenation and serum lactate existsSecondary objectives:- To provide data for estimating the number of patients needed for a clinical trial to prove the above…
ID
Source
Brief title
Condition
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- MitoPO2 (mmHg) measured semi-continuously peri-operatively and during 48
hours post-operatively using the automated setting of the COMET-device
- Arterial lactate levels (mmol/l) measured four times per 24 hours or until
available
Secondary outcome
- Feasibility and accuracy of COMET measurements in an awake population during
a 48 hr post-operative trajectory will be judged based on signal quality of the
measurements during this period and the experiences of the researchers and
patients
- The capability of the 5-ALA patch to provide 5-ALA which will be metabolized
into PpIX for the purpose of fluorescence-based measurements will be evaluated
by the signal quality of the mitoPO2 measurements after prolonged hours of
measurements, defined as over 24 hours of measurements. This can be evaluated
without involvement of the patient.
- Adverse events will be monitored throughout the study period. Special
attention will be attenuated to the plaster site by daily investigation.
Subjects will be asked if any physical discomfort has taken place and their
overall experience.
- Experience of patients regarding the ALA-plasters, COMET Sensor Holder and
measurements, collected during a telephone call two weeks after their hospital
admission
- Laboratory values (hemoglobin mmol/l, ALAT U/l, ASAT U/l and creatinine
umol/l) are sampled according to standard care
- Urine production and fluid balance during ICU/PACU admission, measured during
standard care will be registered
- Throughout the operation and the first 24 hours on the ICU, standard
hemodynamic parameters, such as blood pressure (mmHg), heart rate (bpm) and
oxygen saturation (%) are recorded every minute during the operation and every
15 minutes on the ICU. On the ward they are measured and recorded three times a
day.
- Clinical outcome, such as length of ICU stay, length of hospital stay
- Post-operative complications, especially wound infection and impaired kidney
function. Kidney function will be based on serum creatinine and urine production
- The effect of time interval on signal quality will be judged based on signal
quality of measurements with different time-intervals
- Delta temperature (measured non-invasively, using core temperature (e.g.
tympanic) and skin temperature), capillary refill
Background summary
Lactate is produced during anaerobic metabolism and is commonly used as a
marker for inadequate tissue perfusion. As studies show that even a small rise
in lactate levels is associated with increased morbidity and mortality, therapy
strategies have been based on increasing lactate clearance and reducing lactate
levels. Since lactate changes take place over hours, a more sensitive
monitoring parameter has been long sought after. Previous studies have shown
the potential of the recently introduced Cellular Oxygen METabolism (COMET)
monitor (Phototonics Healthcare, Utrecht), which measures cutaneous
mitochondrial oxygen tension (mitoPO2) and oxygen consumption (mitoVO2).This
study will provide the base for future studies which investigate whether
mitochondrial oxygen monitoring can predict changes in serum lactate and if it
can be used as a tool for optimizing hemodynamic management.
Study objective
Primary objectives:
- To test the hypothesis that a relationship between mitochondrial oxygenation
and serum lactate exists
Secondary objectives:
- To provide data for estimating the number of patients needed for a clinical
trial to prove the above mentioned relationship and/or its clinical
significance.
- To test the feasibility and accuracy of COMET-measurements in an awake
population during a 48 hr post-operative trajectory.
-To observe the duration of acceptable measurements after using a single
plaster. Acceptable measurements are defined as measurements with a signal
quality of at least 20%.
-To observe adverse events related to the prolonged usage of aminolevulinic
acid plasters in combination with the COMET-measurement device.
-To observe the relation between low mitochondrial oxygen tension in the skin
and post-operative outcome, especially wound infections and kidney function.
- To provide information on relevant clinical parameters associated with tissue
hypoxia, fluid balance and liver function
Study design
Single center observational pilot study
Study burden and risks
The intracellular oxygen measurements performed by the COMET are non-invasive
and do not require deviation from standard protocol. Mild possible physical
discomfort may arise from use of the aminolevulinic acid plaster or the
armpiece (COMET Sensor Holder) which will be attached to the arm during the
study period. All patients will receive an arterial catheter on the day of the
operation, placed by skilled personnel. Arterial blood sampling via the
arterial catheter will be performed four times per 24 hours, adhering to
standard care as much as possible. The sampling is painless and does not cost
the patient extra time. After discharge to the clinical ward, the time point
where standard of care requires removal of the arterial line, further blood
lactate analysis will be performed using arterial needle punctures. This
sampling strategy can cause discomfort, but serious complications are rare.
Overall the risks are considered negligible and the burden low.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Age over 18 years
Acceptable proficiency of the Dutch language
Scheduled for major abdominal surgery, the primary focus will be on liver
resection and liver transplantation surgery
Written informed consent has been signed prior to or on admission to the
surgical ward before surgery
Exclusion criteria
Presence of mitochondrial disease
Pregnancy/lactation
Patients with skin lesions on upper arm/shoulder which impede measurements
Porphyria
Known intolerance to components of the ALA plaster
Patients uncapable of providing informed consent, due to a mental condition
interfering with the ability to understand the provided information
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL74651.078.20 |
| OMON | NL-OMON28542 |