Mitochondrial Oxygen Measurement Variability in Critically Ill Patients: Validation of the COMET Measurement System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Within-subject variability of mitochondrial oxygenation measurements over a period of 24 hours after ALA-induction
研究概览
简要总结
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.
详细描述
Rationale:
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 intensive care unit (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.
Main objectives:
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 or MC. 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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Within-subject variability of mitochondrial oxygenation measurements over a period of 24 hours after ALA-induction
时间窗: 24 hours
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
次要结局
- Between- and within-subject variability between 3 hour offset 5-aminolevulinic acid-patches(24 hour)
- Safety of mitochondrial oxygenation measurements(48 hours)
研究者
J.G. van der Bom
Professor J.G. van der Bom
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research