Clinical Trial: Proteomics for Identification of Hyperoxia-induced Changes in Protein Expression

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Proteomics for Identification of Hyperoxia-induced Changes in Protein Expression

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 Summary:

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 subsequen
Sponsor: University Hospital of Cologne

Current Primary Outcome: Comparison of proteomics changes before and after short-term hyperoxia [ Time Frame: 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Spirometry Results: Forced vital capacity (FVC) [L] [ Time Frame: 2 days ]
  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] [ Time Frame: 2 days ]
  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] [ Time Frame: 2 days ]
  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] [ Time Frame: 2 days ]
  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] [ Time Frame: 3 hours ]
  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] [ Time Frame: 3 hours ]
  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] [ Time Frame: 3 hours ]
  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) [%] [ Time Frame: 3 hours ]
  Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.

Original Secondary Outcome: Same as current

Information By: University Hospital of Cologne

Dates:
Date Received: July 9, 2015
Date Started: October 2015
Date Completion: December 2016
Last Updated: September 16, 2015
Last Verified: September 2015