Trial document




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  DRKS00016670

Trial Description

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Title

A pilot study on the association of the ergospirometric evaluation of gas metabolism and cellular oxygen metabolism measured by the Cellular Oxygen METabolism Monitor (COMET)

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Trial Acronym

SPICOMET

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URL of the Trial

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Brief Summary in Lay Language

An adequate oxygen supply is essential for our survival and serves primarily the energy production in our cells. Unlike other methods the CE-certified COMET-System can measure oxygen supply at this level. Via the protoporphirin-IX-triple state lifetime technique the presence and consumption of oxygen can be determined non-invasively (without tissue sampling) and in real time. This method has potentially a great relevance for patient monitoring at the intensive care unit or during surgery. It may support therapy decisions in patients with insufficient oxygen supply, e.g. after massive blood loss.
In an own pilot study (PICOMET, DRKS-ID: DRKS00014033) we analysed activity-induced changes on the cellular oxygen supply. We showed that increased activity leads to decreased cellular oxygen consumption and additionally cellular oxygen levels are increased during activity. To gain a deeper insight in oxygen uptake during physical activity and cellular oxygen consumption several COMET-measurements will be performed during spiroergometry. During this investigation the physical activity will be increased in a standardised way and the breathing air will be analysed at the same time.

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Brief Summary in Scientific Language

An adequate oxygen supply is essential for our survival. To sustain the integrity and the functioning tissue cells need energy in the form of ATP which is produced by means of mitochondrial oxidative phosphorylation. The measurement of mitochondrial oxygen tension (mitoPO2) seems very attractive since it is a direct marker for oxygen supply at a physiologically meaningful level. Next to the mitoPO2 the mitochondrial oxygen consumption (mitoVO2) and mitochondrial oxygen delivery (mitoDO2) can be obtained during dynamic measurements. Here, the local oxygen supply is temporarily interrupted by the application of pressure and the mitoVO2 is determined by the oxygen disappearance rate (ODR). After the pressure is released, the skin area is re-oxygenated, which can be described with mitoDO2.
Via the protoporphirin-IX-triple state lifetime technique (PpIX-TSLT) the COMET-variables (mitoPO2, mitoVO2, mitoDO2) can be measured non-invasively and in real time. Essentially, this technique is based on the oxygen dependent delayed fluorescence of PpIX in mitochondria. In pre-clinical studies the PpIX-TSLT was used to study pathophysiological states like mitochondrial dysfunction in sepsis or oxygen-monitoring during hemodilution. These studies underline the potential importance of this method for patient-monitoring at the intensive care unit or during surgery. With the development of the COMET-system a CE-certified medical device is available for the application of the PpIX-TSLT in humans.
In an own pilot study (PICOMET, DRKS-ID: DRKS00014033) we investigated the influence of cardiovascular activation on the COMET variables mitoPO2, mitoVO2 and mitoDO2. We showed that an increase in activity is associated with a decrease in mitoVO2 and that an increase in mitoPO2 can be observed during ergometry. In order to gain a deeper understanding of oxygen uptake during physical activity and mitochondrial oxygen metabolism, various COMET measurements will be performed in the current study using spiroergometry. The focus is on the association between mitochondrial oxygen consumption (mitoVO2) and spiroergometrically measured oxygen uptake (VO2).

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Organizational Data

  •   DRKS00016670
  •   2019/02/21
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  •   yes
  •   Approved
  •   2019-1296-BO, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   healthy subjects
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Interventions/Observational Groups

  •   T0:
    written and informed consent
    application Electrocardiography
    preparation spiroergometry

    T1 [Baseline]:
    dynamic COMET measurement
    respiratory gas analysis without exercise
    measurement of heart frequency, pulse oximetry and blood pressure
    capillary blood sample (blood gas analysis/lactate measurement)

    T2 [physical exercise]:
    Spiroergometry*
    dynamic COMET measurement (for every load level)
    measurement of heart frequency, pulse oximetry and blood pressure (for every load level)
    capillary blood sample (blood gas analysis/lactate measurement at the end of every load level)

    T3 [recovery phase]:
    dynamic COMET measurement
    respiratory gas analysis without exercise
    measurement of heart frequency, pulse oximetry and blood pressure
    capillary blood sample (blood gas analysis/lactate measurement)

    T4 [post]:
    dynamic COMET measurement
    respiratory gas analysis without exercise
    measurement of heart frequency, pulse oximetry and blood pressure
    capillary blood sample (blood gas analysis/lactate measurement)


    *
    Start with 50 Watt and 25 Watt increase every 3 minutes | cycling frequency 60-70 rpm

    Individual termination criteria:

    a. Target heart frequency: 208 – 0,7 x Age (for more than 30s)

    b. Maximum load level in Watt (after the end of the load level):
    men: 6,773 + 136,141 x BS – 0,916 x BS x Age (in years)
    women: 3,933 + 86,641 x KO – 0,346 x KO x Alter (in years)

    [BS (body surface): 0,007148 x body mass (in kg)^0,425 x body height (in cm)^0,725]

    c. Respiratory Quotient: > 1.1
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary aim is the evaluation of the association between mitochondrial oxygen consumption (mitoVO2) and the spiroergometrically measured oxygen uptake (VO2) over the time points T1 – T4.

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Secondary Outcome

- Evaluation of the association between mitochondrial oxygen tension (mitoPO2) and the spiroergometrically measured oxygen uptake (VO2) over the time points T1 – T4.

- Evaluation of the association between mitochondrial oxygen delivery (mitoDO2) and the spiroergometrically measured oxygen uptake (VO2) over the time points T1 – T4.

- Corresponding analyses for mitoPO2, mitoVO2 and mitoDO2 and other variables from spiroergometry.

- Corresponding analyses for mitoPO2, mitoVO2 and mitoDO2 and variables from blood gas analysis.

- Characterisation of the course of mitoPO2, mitoVO2 and mitoDO2 between T1 – T4.

Additional research questions:
- Exploratory analysis on the influence of the maximum oxygen intake (VO2:max) on baseline values (T1) of mitoPO2, mitoVO2 and mitoDO2

- Activity induced differences in mitoPO2, mitoVO2 and mitoDO2 between T1 and the last load level during spiroergometry

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2019/02/22
  •   15
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- written and informed consent
- suitability for exercise test (Physical Activity Readiness Questionnaire)

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Exclusion Criteria

- significant pre-existing cardiological or pulmonal disease as well as significant diseases of the musculoskeletal system
-absolute contraindication for 5-aminolevulinic-acid-patch (required 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)
- allergy to Nonivamid or Nicoboxil (ingredients Finalgon®)
- pregnancy/breastfeeding
- participation in another intervention study
- previous participation in this study

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Addresses

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    • NWG Translational Septomics, Zentrum für Innovationskompetenz (ZIK) Septomics, Universitätklinikum Jena
    • Ms.  Dr. Dr. med.  Sina  Coldewey 
    • Am Klinikum 01
    • 07747  Jena
    • Germany
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    • NWG Translational Septomics, Zentrum für Innovationskompetenz (ZKS) Septomics, Universitätsklinikum Jena
    • Ms.  Dr. Dr.med.  Sina  Coldewey 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • NWG Translational Septomics, Zentrum für Innovationskompetenz (ZKS) Septomics, Universitätsklinikum Jena
    • Mr.  Philipp  Baumbach 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF)
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.