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临床试验/NCT02553668
NCT02553668Unknown不适用

Proteomics for Identification of Hyperoxia-induced Changes in Protein Expression

University Hospital of Cologne0 个研究点目标入组 40 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
Comparison of proteomics changes before and after short-term hyperoxia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Hyperoxia

Experimental

Participants receive 100% oxygen

干预措施: Oxygen (FiO2 1,0) (Drug)

Hyperoxia

Experimental

Participants receive 100% oxygen

干预措施: Facemask (Device)

结局指标

主要结局

Comparison of proteomics changes before and after short-term hyperoxia

时间窗: 4 weeks

次要结局

  • Spirometry Results: Forced expiratory flow (FEF25-75) [L/s](2 days)
  • Spirometry Results: Peak expiratory flow (PEF) [L/s](2 days)
  • Vital parameter: Respiratory rate (RR) [1/min](3 hours)
  • Vital parameter: Heart rate (HR) [1/min](3 hours)
  • Vital parameter: Blood pressure (BP) [mmHg](3 hours)
  • Vital parameter: Oxygen saturation (SpO2) [%](3 hours)
  • Spirometry Results: Forced vital capacity (FVC) [L](2 days)
  • Spirometry Results: Forced expiratory volume at one second (FEV1) [L](2 days)

研究者

发起方
University Hospital of Cologne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med. Stefan Braunecker

Anesthesiologist

University Hospital of Cologne

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