Cardioprotective Effects of Increased Endogenous Erythropoietin After Normobaric Oxygen Breathing

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00824759
Collaborator
(none)
0
1
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: pure oxygen breathing versus air
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: placebo

Other: pure oxygen breathing versus air
one group will breath pure oxygen; the other will breath air

Active Comparator: oxygen

Other: pure oxygen breathing versus air
one group will breath pure oxygen; the other will breath air

Outcome Measures

Primary Outcome Measures

  1. decrease in Troponin-I values [12h]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cliniques Universitaires Saint Luc Brussels Belgium 1200

Sponsors and Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Momeni, MD; Chef de Clinique Adjointe, Department of Anesthesiology, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00824759
Other Study ID Numbers:
  • 2008/24NOV/331
First Posted:
Jan 19, 2009
Last Update Posted:
Nov 19, 2014
Last Verified:
Nov 1, 2014
Keywords provided by Momeni, MD; Chef de Clinique Adjointe, Department of Anesthesiology, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Results

No Results Posted as of Nov 19, 2014