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
About this trial
This is an interventional basic science trial for Hyperoxia focused on measuring Proteomics, Oxygen, Pathways
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
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
NCT ID
NCT02553668
First Posted
July 9, 2015
Last Updated
September 16, 2015
Sponsor
University Hospital of Cologne
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
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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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