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Impact of Hyperoxia During Cardiopulmonary (CARDIOX)

C

Centre Hospitalier Universitaire, Amiens

Status and phase

Completed
Phase 3

Conditions

Cardiac Complications

Treatments

Drug: medical oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT02819739
2014-001403-44 (EudraCT Number)
PI2014_843_0006

Details and patient eligibility

About

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.

Enrollment

330 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

330 participants in 2 patient groups

normoxia
Experimental group
Description:
During cardiopulmonary bypass inspired fraction of oxygen is adapted to maintained a oxygen arterial pressure below 150 mmHg.
Treatment:
Drug: medical oxygen
hyperoxia
Active Comparator group
Description:
During cardiopulmonary bypass inspired fraction of oxygen is set to 100 %.
Treatment:
Drug: medical oxygen

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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