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临床试验/NCT00824759
NCT00824759撤回不适用

Cardioprotective Effects of Increased Endogenous Erythropoietin After Normobaric Oxygen Breathing

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家开始时间: 2009年1月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
decrease in Troponin-I values

研究概览

简要总结

Tissue hypoxia is the only accepted trigger for erythropoietin (EPO) production. However, in healthy subjects EPO concentrations have also increased after oxygen breathing. The aim of our study is to confirm these observations.

Besides its main function in erythropoiesis, EPO has also shown tissue protective effects. The second goal of our study is to observe the cardioprotective effects of increased endogenous EPO, induced after normobaric oxygen breathing.

详细描述

Currently, renal tissue hypoxia is the only widely accepted trigger for erythropoietin (EPO) production. However, previous studies in healthy subjects have demonstrated that a sudden and sustained decrease in tissue oxygen level, aside from an absolute low level of tissue oxygen tension, could also act as a trigger for EPO production. To confirm these observations and to clarify an eventual role of free oxygen radicals and antioxidants, hypobaric pure oxygen will be administered to healthy subjects.

The major physiologic function of EPO is thought to be the induction of erythropoiesis. However, a growing body of evidence indicates that EPO has tissue-protective effects and prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of EPO have been shown in human myocardium.

The second goal of our study is to observe the cardioprotective effects of increased endogenous EPO, induced after normobaric oxygen breathing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy non-smokers; patients undergoing CABG under cardiopulmonary bypass

排除标准

  • Subjects with a pulmonary disease; subjects who have stayed at high altitude since at least 3 months; healthy subjects taking medication; patients undergoing a redo or combined cardiac surgery; patients with renal insufficiency; any emergency CABG; Patients with pulmonary disease

研究组 & 干预措施

placebo

Placebo Comparator

干预措施: pure oxygen breathing versus air (Other)

oxygen

Active Comparator

干预措施: pure oxygen breathing versus air (Other)

结局指标

主要结局

decrease in Troponin-I values

时间窗: 12h

次要结局

未报告次要终点

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Principal Investigator
主要研究者

Momeni

MD; Chef de Clinique Adjointe, Department of Anesthesiology

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

研究点 (2)

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