Impact of Hyperoxia During Cardiopulmonary

Cardiac Complications Clinical Trial

— CARDIOX  

Official title:

Impact of Hyperoxia During Cardiopulmonary Bypass in the Occurrence of Cardiovascular Complications After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819739
• Other study ID #: PI2014_843_0006
• Secondary ID: 2014-001403-44
• Status: Completed
• Phase: Phase 3
• Start date: November 11, 2014
• Est. completion date: March 30, 2019

Study information

• Verified date: April 2019
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: March 30, 2019
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Complications
• Hyperoxia

Intervention

Drug:
• medical oxygen

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens
France	CHU Dijon-Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)		15 days after surgery