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Sponsored by: |
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
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Information provided by: | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
ClinicalTrials.gov Identifier: | NCT00824759 |
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.
Condition | Intervention |
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Healthy Coronary Artery Bypass Graft |
Other: pure oxygen breathing versus air |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 50 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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placebo: Placebo Comparator |
Other: pure oxygen breathing versus air
one group will breath pure oxygen; the other will breath air
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oxygen: Active Comparator |
Other: pure oxygen breathing versus air
one group will breath pure oxygen; the other will breath air
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: MONA MOMENI, MD | +32.2764.7029 ext 8am-6pm | mona.momeni@uclouvain.be |
Contact: GIUSEPPE LIISTRO, MD,PhD | giuseppe.liistro@uclouvain.be |
Belgium | |
Cliniques Universitaires Saint Luc | |
Brussels, Belgium, 1200 |
Responsible Party: | Cliniques Universitaires Saint Luc ( MONA MOMENI, MD ) |
Study ID Numbers: | 2008/24NOV/331 |
Study First Received: | January 16, 2009 |
Last Updated: | January 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00824759 History of Changes |
Health Authority: | Belgium: Institutional Review Board |
Healthy subjects CABG Patients undergoing coronary artery bypass graft under cardiopulmonary bypass |
Epoetin Alfa Healthy |