Cardioprotective Effects of Increased Endogenous Erythropoietin After Normobaric Oxygen Breathing

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Withdrawn

Conditions

Coronary Artery Bypass Graft
Healthy

Treatments

Other: pure oxygen breathing versus air

Study type

Interventional

Funder types

Other

Identifiers

NCT00824759
2008/24NOV/331

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups, including a placebo group

placebo
Placebo Comparator group
Treatment:
Other: pure oxygen breathing versus air
oxygen
Active Comparator group
Treatment:
Other: pure oxygen breathing versus air

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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