NCT00824759

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

First QC Date

January 16, 2009

Last Update Submit

November 18, 2014

Conditions

HealthyCoronary Artery Bypass Graft

Keywords

Healthy subjectsCABGPatients undergoing coronary artery bypass graft under cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

  • decrease in Troponin-I values

    12h

Study Arms (2)

placebo

PLACEBO COMPARATOR
Other: pure oxygen breathing versus air

oxygen

ACTIVE COMPARATOR
Other: pure oxygen breathing versus air

Interventions

pure oxygen breathing versus airOTHER

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

oxygenplacebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, Brussels Capital, 1200, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 16239610BACKGROUND

  • 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.

    PMID: 14523037BACKGROUND
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; Chef de Clinique Adjointe, Department of Anesthesiology

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 19, 2009

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

BE(1)