Impact of Hyperoxia During Cardiopulmonary (CARDIOX)

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)

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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