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CompletedNCT02819739CARDIOXUpdated Apr 10, 2019

Impact of Hyperoxia During Cardiopulmonary

A Phase 3 interventional study of medical oxygen in Cardiac Complications, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 2 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by Centre Hospitalier Universitaire, Amiens · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass by his heart preconditioning effect is associated with a lower incidence of cardiac arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of myocardial ischemia-reperfusion injury in cardiac surgery postoperative.

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Conditions studied

  • Cardiac Complications

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03

In context

Hyperoxia

124 studies on the registry are indexed under Hyperoxia; 21 are open to participants now.

This study's enrollment of 330 is above the median of 48 across 99 interventional studies indexed under Hyperoxia.

Browse Hyperoxia studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Major patient ≥ 18 years
  • Patient operated cardiac surgery for myocardial revascularization (CABG) or surgical correction of valvular or combined surgery (CABG and valve disease) or ascending aortic surgery
  • Signed Consent
  • Affiliation to social security

Exclusion criteria

Exclusion Criteria:

  • Permanent atrial fibrillation
  • Cordarone therapy,
  • Pregnant woman
  • Patient under guardianship or trusteeship or private public law
  • Internal pacemaker
  • Hypothermia,
  • Patient refusal,
  • Cardiac surgery without extracorporal circulation (ECC),
  • Participation in another study.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
330 participants (actual)

Study arms

  • Experimental
    normoxia

    During cardiopulmonary bypass inspired fraction of oxygen is adapted to maintained a oxygen arterial pressure below 150 mmHg.

    Drug: medical oxygen

  • Active comparator
    hyperoxia

    During cardiopulmonary bypass inspired fraction of oxygen is set to 100 %.

    Drug: medical oxygen

Interventions

  • Drugmedical oxygen
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What researchers measure

Primary outcomes

  1. Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)

    Time frame: 15 days after surgery

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Study locations

2 sites
  • CHU Amiens-Picardie
    Amiens, 80054, France
  • CHU Dijon-Bourgogne
    Dijon, 21079, France
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References and documents

Publications

  • Abou-Arab O, Huette P, Martineau L, Beauvalot C, Beyls C, Josse E, Touati G, Bouchot O, Bouhemad B, Diouf M, Lorne E, Guinot PG. Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial. Intensive Care Med. 2019 Oct;45(10):1413-1421. doi: 10.1007/s00134-019-05761-4. Epub 2019 Oct 1. PubMed 31576438 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02819739
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jun 30, 2016
Start date
Nov 11, 2014
Primary completion
Oct 10, 2018
Completion
Mar 30, 2019
Last update
Apr 10, 2019

Study contacts

Osama ABOU ARAB, Doctor
principal investigator · CHU Amiens-Picardie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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