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临床试验/DRKS00014033
DRKS00014033已完成未知

A pilot study on exercise induced changes in cellular oxygen metabolism measured by the Cellular Oxygen METabolism Monitor (COMET) - PICOMET

WG Translational Septomics, Zentrum für Innovationskomepetenz (ZIK) Septomics, Universitätklinikum Jena0 个研究点目标入组 40 人开始时间: 2018年2月15日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
40

研究概览

简要总结

Impaired tissue oxygenation is the key pathomechanism in the development of organ dysfunction in shock; mitochondrial impairment can aggravate the condition. However, measuring tissue oxygenation directly and non-invasively still poses a clinical challenge. A novel device (COMET) allows the assessment of mitochondrial oxygen metabolism using the Protoporphyrin IX Triplet State Lifetime Technique (PpIX-TSLT). Critically ill patients, especially in sepsis, often exhibit oedema which may interfere with the COMET measurement. Furthermore, patients' physical activity level differs significantly before and during hospitalisation. Thus, the aim of this study was to identify the effects of physical activity and body composition on mitochondrial oxygen tension (mitoPO2) and consumption (mitoVO2) in healthy controls (N = 40). Furthermore, the study tested the repeatability of the COMET variables and identified covariates. Multiple COMET measurements were performed before (T1, T2), during and after (T3, T4) ergometry. Body composition was assessed by bioimpedance analysis. Physiological variables (blood pressure, heart rate, oxygen saturation) were recorded. In the analytical sample (n = 26), physical activity significantly decreased mitoVO2; other COMET variables remained unchanged between T2 and T3. During ergometry, mitoPO2 increased significantly. The distribution of body water significantly influenced mitoVO2. In our setting, the method demonstrated moderate repeatability. Variables of fitness (heart rate recovery, phase angle and physical activity level), signal quality and duration of exposure to 5-aminolevulinic acid (obligatory for PpIX-TSLT) were identified as significant covariates of mitoVO2. Mitochondrial oxygen delivery (mitoDO2) was established as a new variable of COMET analysis. Results of this pilot study should be validated in future studies.

研究设计

研究类型
Interventional
分配方式
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 85 Years(—)
性别
All

入选标准

  • age >18 years
  • - written and informed consent
  • - suitability for exercise test (Physical Activity Readiness Questionnaire)

排除标准

  • - significant pre-existing cardiological or pulmonal disease as well as significant diseases of the musculoskeletal system
  • -absolute contraindication for 5-aminolevulinic-acid-patch (for COMET measurement):
  • allergy to 5-aminolevulinic-acid-hydrocholride, acrylic adhesives, pigmented polyethylene or aluminized polyester
  • - porphyria, skin disease which are caused or aggravated by sun light, increased sensitivity to sun light
  • - pregnancy/breastfeeding
  • - participation in another intervention study
  • - previous participation in this study

研究者

发起方
WG Translational Septomics, Zentrum für Innovationskomepetenz (ZIK) Septomics, Universitätklinikum Jena

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