To describe the between- and within-subject variability of mitoPO2 measurements during a 24 hour period after 5- aminolevulinic acid (ALA)-induction among healthy volunteers and among neurosurgical patients admitted postoperatively to the ICU, MC,…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Between- and within-subject variability (assessed by standard deviation) of
mitoPO2 measurements over a period of 24 hours after ALA-induction.
- Initially in healthy volunteers
- Followed by neurosurgical patients admitted postoperatively to the ICU or MC,
PACU or other hospital ward.
Secondary outcome
Secondary endpoints:
- Description of the differences in the between- and within-subject variability
between 3 hour offset ALA-patches.
- Description of between- and within-subject variability in healthy volunteers
and neurosurgical patients in relation to the between- and within-subject
variability of the INOX ICU-2 pilot study (NL59512.058.16)
- Report on adverse and serious adverse events of the mitoPO2 measurements.
Background summary
Recent studies have shown the potential of a protoporphyrin IX-triple state
lifetime technique to measure mitochondrial oxygen tension (mitoPO2) in vivo,
which possibly is an early indicator of oxygen disbalance in the cell. With the
advent of the COMET measurement system, steps have been made to determine the
feasibility of this measurement method. The INOX ICU-2 study (parent study)
aims to tailor transfusion therapies to individual ICU patients based on
mitochondrial oxygen tension. In the pilot study of the INOX ICU-2 study, in
which the COMET measurement system was used on critically ill patients
receiving red blood cell transfusion, an increase in the between- and
within-subject variability was observed over time. This deviation was not
explored during the development of the COMET measurement system. Therefore, we
aim to determine the between- and within-subject variability of this
measurement in healthy subjects and in hemodynamically stable subjects at the
intensive care unit.
Study objective
To describe the between- and within-subject variability of mitoPO2 measurements
during a 24 hour period after 5- aminolevulinic acid (ALA)-induction among
healthy volunteers and among neurosurgical patients admitted postoperatively to
the ICU, MC, PACU or other hospital ward. Healthy subjects allow for the
exploration of the effect of time-since-application of ALA-patch and
neurosurgical patients allow for the exploration of a possible effect of (ICU-)
admittance.
Study design
Prospective cohort study
Study burden and risks
The risks are small in this study with no serious adverse events (SAE) known.
The burden for participants is small since it involves a non-invasive
measurement. We will perform this study first in health volunteers. Following
the healthy volunteers, neurosurgical patients will be included. Patients will
undergo neurosurgery as planned and common practice is that no major
interventions are needed in the postoperative phase on the ICU, PACU or orther
hospital ward. Normal clinical practice will continue and will not be altered.
These patients will allow for the exploration of a possible effect of (ICU)
admittance.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Patients meeting all these criteria will be included in the study:
• Age of patient is at least 18 years
• Healthy participants, defined as the absence of active or chronic disease
(applicable only to healthy volunteer group).
• Patients are admitted to the intensive care unit, medium care, PACU or other
hospital ward after neurosurgery (applicable only to neurosurgery group).
Exclusion criteria
Patient meeting one of these criteria will be excluded from the study:
• pregnant or breast feeding women since there is no adequate data from the use
of ALA in pregnant or breast feeding women
• patients with porphyria and/or known photodermatosis
• patients with hypersensitivity to the active substance or to the plaster
material of ALA
• insufficient comprehensibility of the Dutch language
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT04626661 |
| CCMO | NL71914.058.19 |