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Proteomics for Identification of Hyperoxia-induced Changes in Protein Expression

Primary Purpose

Hyperoxia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxygen (FiO2 1,0)
Facemask
Sponsored by
University Hospital of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperoxia focused on measuring Proteomics, Oxygen, Pathways

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) 1
  • >18 years
  • < 50 years

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) > 1
  • pregnant
  • <18 years
  • > 50 years
  • frequent or recent drug intake

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hyperoxia

    Arm Description

    Participants receive 100% oxygen

    Outcomes

    Primary Outcome Measures

    Comparison of proteomics changes before and after short-term hyperoxia

    Secondary Outcome Measures

    Spirometry Results: Forced vital capacity (FVC) [L]
    Spirometry will be used as a measure of safety to rule out adverse events of oxygen to the lung.
    Spirometry Results: Forced expiratory volume at one second (FEV1) [L]
    Spirometry will be used as a measure of safety to rule out adverse events of oxygen to the lung.
    Spirometry Results: Forced expiratory flow (FEF25-75) [L/s]
    Spirometry will be used as a measure of safety to rule out adverse events of oxygen to the lung.
    Spirometry Results: Peak expiratory flow (PEF) [L/s]
    Spirometry will be used as a measure of safety to rule out adverse events of oxygen to the lung.
    Vital parameter: Respiratory rate (RR) [1/min]
    Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.
    Vital parameter: Heart rate (HR) [1/min]
    Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.
    Vital parameter: Blood pressure (BP) [mmHg]
    Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.
    Vital parameter: Oxygen saturation (SpO2) [%]
    Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.

    Full Information

    First Posted
    July 9, 2015
    Last Updated
    September 16, 2015
    Sponsor
    University Hospital of Cologne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02553668
    Brief Title
    Proteomics for Identification of Hyperoxia-induced Changes in Protein Expression
    Official Title
    Proteomics for Identification of Hyperoxia-induced Changes in Protein Expression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    October 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital of Cologne

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aim of the present study is to investigate the influence of hyperoxia on the protein expression using the differential analysis of protein expression in tissues (proteomics). In the study, blood and urine samples will be collected from participants who undergo a short term hyperoxia using 100% oxgen for 3 hours. Here, gel electrophoresis, protein separation and mass spectroscopy allow to identify affected proteins. Based on these results, different induction factors of proteins will be determined and then assessed using a bioinformatic network analysis regarding the cellular influence.
    Detailed Description
    Oxygen is necessary to sustain human life and is used for energy production by oxidation in the mitochondria. Application of oxygen not only increases saturation in the patient's blood, but also has various secondary effects. It is therefore used to treat diseases that impairs body's ability to take up and use oxygen. But even healthy people can suffer from hypoxia when they ascend to high altitude. Here, altitude sickness can lead to potentially fatal complications such as high altitude cerebral edema or high altitude pulmonary edema. Since hypoxia can have disastrous consequences, hyperoxia is often tolerated in many pre- and in-hospital situations. Whereas the effects of hypoxia are well studied, especially publications in the last decade have led to a new perspective on oxygen application. Besides pathophysiological changes as the peripheral vasoconstriction or reduction of contractility, especially changes on cellular level seem to be of great importance. Here, oxidative stress and change of protein synthesis in various organ are focus of current studies. The differential analysis of protein expression in tissues (proteomics) is an important approach for better understanding of the negative effects of hyperoxia. Especially for patients with long-term high oxygen demand the knowledge of cellular changes during hyperoxia can result in new therapeutic approaches and a reduction in the rate of complications. In the present molecular biology study urine and blood samples of healthy volunteers will be collected at specified times after short-term exposure to oxygen. These samples will be analyzed after the study using the differential analysis of protein expression. The aim of this study is to investigate the effects of oxygen on the cell functions by analyzing and subsequent bioinformatic processing of differentially regulated proteins in the blood and urine. After checking the inclusion and exclusion criteria biometric data of the test persons are collected. Before short-term hyperoxia a sample collection of blood and urine will be performed. Here the participants are taken 5 ml of venous blood from the cephalic vein under sterile conditions. To obtain the urine sample spontaneous urine of participants is used. The samples are immediately centrifuged and flash frozen at -80°C. In order to exclude impairment of the lung prior to the short-term hyperoxia a pulmonary function test is carried out by using a hand spirometer. To induce hyperoxia subjects inhale 100% oxygen for 3 hours through a face mask. After carrying out the short term hyperoxia the follow up phase takes place. In this phase blood and urine samples from the subjects will be obtained directly after the hyperoxia (T0), on day 1 (T1), day 3 (T3), day 7 (T7), day 14 (T14), day 21 (T21) and day 28 (T28) after oxygen exposure. All samples will be centrifuged immediately after collection and flash frozen at -80 ° C. To exclude hyperoxia-induced lung impairments, a spirometry is performed during the follow up. After the samples of all subjects were collected the analysis of the samples will be carried out using Proteomics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperoxia
    Keywords
    Proteomics, Oxygen, Pathways

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hyperoxia
    Arm Type
    Experimental
    Arm Description
    Participants receive 100% oxygen
    Intervention Type
    Drug
    Intervention Name(s)
    Oxygen (FiO2 1,0)
    Intervention Description
    Participants will inhale Oxygen (FiO2 1,0) via Facemask for 3 hours.
    Intervention Type
    Device
    Intervention Name(s)
    Facemask
    Primary Outcome Measure Information:
    Title
    Comparison of proteomics changes before and after short-term hyperoxia
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Spirometry Results: Forced vital capacity (FVC) [L]
    Description
    Spirometry will be used as a measure of safety to rule out adverse events of oxygen to the lung.
    Time Frame
    2 days
    Title
    Spirometry Results: Forced expiratory volume at one second (FEV1) [L]
    Description
    Spirometry will be used as a measure of safety to rule out adverse events of oxygen to the lung.
    Time Frame
    2 days
    Title
    Spirometry Results: Forced expiratory flow (FEF25-75) [L/s]
    Description
    Spirometry will be used as a measure of safety to rule out adverse events of oxygen to the lung.
    Time Frame
    2 days
    Title
    Spirometry Results: Peak expiratory flow (PEF) [L/s]
    Description
    Spirometry will be used as a measure of safety to rule out adverse events of oxygen to the lung.
    Time Frame
    2 days
    Title
    Vital parameter: Respiratory rate (RR) [1/min]
    Description
    Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.
    Time Frame
    3 hours
    Title
    Vital parameter: Heart rate (HR) [1/min]
    Description
    Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.
    Time Frame
    3 hours
    Title
    Vital parameter: Blood pressure (BP) [mmHg]
    Description
    Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.
    Time Frame
    3 hours
    Title
    Vital parameter: Oxygen saturation (SpO2) [%]
    Description
    Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.
    Time Frame
    3 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) 1 >18 years < 50 years Exclusion Criteria: American Society of Anesthesiologists (ASA) > 1 pregnant <18 years > 50 years frequent or recent drug intake
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stefan Braunecker, M.D.
    Email
    stefan.braunecker@uk-koeln.de
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jochen Hinkelbein, M.D.
    Email
    jochen.hinkelbein@uk-koeln.de
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stefan Braunecker, M.D.
    Organizational Affiliation
    Universityhospital of Cologne
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23934118
    Citation
    Spelten O, Wetsch WA, Wrettos G, Kalenka A, Hinkelbein J. Response of rat lung tissue to short-term hyperoxia: a proteomic approach. Mol Cell Biochem. 2013 Nov;383(1-2):231-42. doi: 10.1007/s11010-013-1771-y. Epub 2013 Aug 11.
    Results Reference
    background
    PubMed Identifier
    20049628
    Citation
    Hinkelbein J, Feldmann RE Jr, Kalenka A. Time-dependent alterations of cerebral proteins following short-term normobaric hyperoxia. Mol Cell Biochem. 2010 Jun;339(1-2):9-21. doi: 10.1007/s11010-009-0365-1. Epub 2010 Jan 5.
    Results Reference
    background

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    Proteomics for Identification of Hyperoxia-induced Changes in Protein Expression

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