Mitochondrial Oxygen Measurement Variability in Critically Ill Patients (INOX Variability Study)

NCT04626661 | Completed

• 1 other identifier: NL71914.058.19
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the between- and within-subject variability of the mitochondrial oxygenation measurement with the COMET device over time in healthy subjects and in hemodynamically stable subjects admitted to the intensive care unit.

Conditions

Mitochondrial Oxygenation Measurement; Measurement Error; Healthy

Outcome Measures

Primary Outcomes (1)

• Within-subject variability of mitochondrial oxygenation measurements over a period of 24 hours after ALA-induction

  To describe the between- and within-subject variability (assessed by standard deviation) of mitoPO2 measurements over a period of 24 hours after ALA-induction in healthy volunteers and in neurosurgical patients

  24 hours

Secondary Outcomes (2)

• Between- and within-subject variability between 3 hour offset 5-aminolevulinic acid-patches

  24 hour

• Safety of mitochondrial oxygenation measurements

  48 hours

Study Arms (2)

Health volunteers

The study population will consist, initially, of healthy volunteers. This group was chosen to perform measurements on, to eliminate the effect of critical illness and interventions on the critically ill patients and to better explore the effect of time-since-application of the 5-aminolevulinic acid-patches.

Device: COMET measurement system

Patients admitted to the ICU after neurosurgery

This study population will consist of patients undergoing elective neurosurgery with planned postoperative recovery of at least 24 hours in the intensive care unit or medium care unit. Leiden University Medical Center is a neurosurgical center in which a wide variety of surgeries including tumor resection in the posterior cranial fossa (including vestibular schwannoma) are performed. Clinical experience has shown that this cohort of patients are in general, hemodynamically the most stable patients and receive the least amount of interventions compared to other cohorts of patients in the intensive care unit and medium care unit. For these reasons, the cohort of elective neurosurgical patients would be ideal to investigate the reason of the increased between- and within-subject variability of mitochondrial oxygen tension in the intensive care unit and medium care unit setting.

Device: COMET measurement system

Interventions

COMET measurement system DEVICE

Photonics Healthcare B.V. has developed an innovative non-invasive bedside monitoring system to measure Cellular Oxygen METabolism (the COMET).The COMET's non-invasive cutaneous mitoPO2 measurements rely on the protoporphyrin IX-triple state lifetime technique (PpIX-TSLT). This technique measures oxygen by oxygen-dependent quenching of delayed fluorescence lifetime of 5-aminolevulinic acid-induced mitochondrial PpIX (protoporphyrin IX). PpIX is the final precursor of haem in the haem biosynthesis pathway and is synthetized in the mitochondria. Administration of exogenous 5-aminolevulinic acid enhances PpIX to detectable levels and enhances mitochondrial origin of the delayed fluorescence signal. Measurements are based on the detection of time of extinction of red light emitted by the tissue following excitation with green light. The technique has been tested and calibrated for use in isolated organs and in vivo.

Health volunteers; Patients admitted to the ICU after neurosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist, initially, of healthy volunteers. This group was chosen to perform measurements on, to eliminate the effect of critical illness and interventions on the ICU and to better explore the effect of time-since-application of the ALA-patches. Neurosurgical ICU/MC patients will subsequently be included to further explore the effect of critical illness (ICU admission). Since this cohort of patients receives minimal interventions, they are ideal to limit potential affecters on the between- and therefore also the within-subject variability.

You may qualify if:

• 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 ICU or MC after neurosurgery (applicable only to neurosurgery group).

You may not qualify if:

• patients without a legal representative in case the patient is not able to give informed consent
• 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

Sponsors & Collaborators

• Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research: lead
• Leiden University Medical Center: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (1)

• Baysan M, Broere M, Wille ME, Bergsma JE, Mik EG, Juffermans NP, Tsonaka R, van der Bom JG, Arbous SM. Description of mitochondrial oxygen tension and its variability in healthy volunteers. PLoS One. 2024 Jun 3;19(6):e0300602. doi: 10.1371/journal.pone.0300602. eCollection 2024.

  PMID: 38829894 DERIVED

Study Officials

• J. G. van der Bom, PhD, MD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

• M. S. Arbous, PhD,MD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor J.G. van der Bom

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: June 15, 2020
• Primary Completion: March 1, 2023
• Study Completion: May 17, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

NL (1)