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Cardioprotective Effects of Increased Endogenous Erythropoietin After Normobaric Oxygen Breathing

NCT ID: NCT00824759

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Coronary Artery Bypass Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

pure oxygen breathing versus air

Intervention Type OTHER

one group will breath pure oxygen; the other will breath air

oxygen

Group Type ACTIVE_COMPARATOR

pure oxygen breathing versus air

Intervention Type OTHER

one group will breath pure oxygen; the other will breath air

Interventions

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pure oxygen breathing versus air

one group will breath pure oxygen; the other will breath air

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Momeni

MD; Chef de Clinique Adjointe, Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, Belgium

Site Status

Countries

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Belgium

References

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Balestra C, Germonpre P, Poortmans JR, Marroni A. Serum erythropoietin levels in healthy humans after a short period of normobaric and hyperbaric oxygen breathing: the "normobaric oxygen paradox". J Appl Physiol (1985). 2006 Feb;100(2):512-8. doi: 10.1152/japplphysiol.00964.2005. Epub 2005 Oct 20.

Reference Type BACKGROUND
PMID: 16239610 (View on PubMed)

Parsa CJ, Matsumoto A, Kim J, Riel RU, Pascal LS, Walton GB, Thompson RB, Petrofski JA, Annex BH, Stamler JS, Koch WJ. A novel protective effect of erythropoietin in the infarcted heart. J Clin Invest. 2003 Oct;112(7):999-1007. doi: 10.1172/JCI18200.

Reference Type BACKGROUND
PMID: 14523037 (View on PubMed)

Other Identifiers

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2008/24NOV/331

Identifier Type: -

Identifier Source: org_study_id