Impact of Hyperoxia During Cardiopulmonary (CARDIOX)
Primary Purpose
Cardiac Complications
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
medical oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Complications
Eligibility Criteria
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.
Sites / Locations
- CHU Amiens-Picardie
- CHU Dijon-Bourgogne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
normoxia
hyperoxia
Arm Description
During cardiopulmonary bypass inspired fraction of oxygen is adapted to maintained a oxygen arterial pressure below 150 mmHg.
During cardiopulmonary bypass inspired fraction of oxygen is set to 100 %.
Outcomes
Primary Outcome Measures
Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)
Secondary Outcome Measures
Full Information
NCT ID
NCT02819739
First Posted
January 5, 2015
Last Updated
April 9, 2019
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT02819739
Brief Title
Impact of Hyperoxia During Cardiopulmonary
Acronym
CARDIOX
Official Title
Impact of Hyperoxia During Cardiopulmonary Bypass in the Occurrence of Cardiovascular Complications After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 11, 2014 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
March 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normoxia
Arm Type
Experimental
Arm Description
During cardiopulmonary bypass inspired fraction of oxygen is adapted to maintained a oxygen arterial pressure below 150 mmHg.
Arm Title
hyperoxia
Arm Type
Active Comparator
Arm Description
During cardiopulmonary bypass inspired fraction of oxygen is set to 100 %.
Intervention Type
Drug
Intervention Name(s)
medical oxygen
Primary Outcome Measure Information:
Title
Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)
Time Frame
15 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama ABOU ARAB, Doctor
Organizational Affiliation
CHU Amiens-Picardie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Dijon-Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31576438
Citation
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.
Results Reference
derived
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Impact of Hyperoxia During Cardiopulmonary
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