Impact of Hyperoxia During Cardiopulmonary
CARDIOX
2 other identifiers
interventional
330
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2014
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2014
CompletedFirst Submitted
Initial submission to the registry
January 5, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedApril 10, 2019
April 1, 2019
3.9 years
January 5, 2015
April 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)
15 days after surgery
Study Arms (2)
normoxia
EXPERIMENTALDuring cardiopulmonary bypass inspired fraction of oxygen is adapted to maintained a oxygen arterial pressure below 150 mmHg.
hyperoxia
ACTIVE COMPARATORDuring cardiopulmonary bypass inspired fraction of oxygen is set to 100 %.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU Amiens-Picardie
Amiens, 80054, France
CHU Dijon-Bourgogne
Dijon, 21079, France
Related Publications (1)
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.
PMID: 31576438DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Osama ABOU ARAB, Doctor
CHU Amiens-Picardie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2015
First Posted
June 30, 2016
Study Start
November 11, 2014
Primary Completion
October 10, 2018
Study Completion
March 30, 2019
Last Updated
April 10, 2019
Record last verified: 2019-04