Cardiac ComplicationsPhase 3CARDIOXNCT02819739
Impact of Hyperoxia During Cardiopulmonary
A Phase 3 study testing medical oxygen in people with Cardiac Complications, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Complications
- What is being tested?
- medical oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Nov 2014to 30 Mar 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Permanent atrial fibrillation
- Cordarone therapy,
- Pregnant woman
- Patient under guardianship or trusteeship or private public law
- Internal pacemaker
- Hypothermia,
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- Patient refusal,
- Cardiac surgery without extracorporal circulation (ECC),
- Participation in another study.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Amiens-Picardie
Amiens, 80054
CHU Dijon-Bourgogne
Dijon, 21079
About this study
Official title: Impact of Hyperoxia During Cardiopulmonary Bypass in the Occurrence of Cardiovascular Complications After Cardiac Surgery
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.
- Conditions
- Cardiac Complications
- Being tested
- medical oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical oxygenDrug
| Study group | Role | What they receive |
|---|---|---|
| normoxia | Experimental | During cardiopulmonary bypass inspired fraction of oxygen is adapted to maintained a oxygen arterial pressure below 150 mmHg. Receives: Drug: medical oxygen |
| hyperoxia | Active comparator | During cardiopulmonary bypass inspired fraction of oxygen is set to 100 %. Receives: Drug: medical oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)
Measured: 15 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start11 Nov 2014
- Primary completion10 Oct 2018
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ComplicationsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osama ABOU ARAB, Doctor, Principal investigator, CHU Amiens-Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819739
- Sponsor's protocol ID
- PI2014_843_0006
- Other IDs
- 2014-001403-44, 2014
- Acronym
- CARDIOX
- Status last verified
- Apr 2019
- First submitted
- 5 Jan 2015
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31576438
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hyperoxia During Cardiopulmonary Bypass in the Occurrence of Cardiovascular Complications After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02819739
- Acronym / sponsor ID
- CARDIOX / PI2014_843_0006
- Conditions
- Cardiac Complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 11 Nov 2014 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normoxia | Experimental | Drug: medical oxygenDuring cardiopulmonary bypass inspired fraction of oxygen is adapted to maintained a oxygen arterial pressure below 150 mmHg. |
| hyperoxia | Active comparator | Drug: medical oxygenDuring cardiopulmonary bypass inspired fraction of oxygen is set to 100 %. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Permanent atrial fibrillation
- Cordarone therapy,
- Pregnant woman
- Patient under guardianship or trusteeship or private public law
- Internal pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical oxygen | Drug | hyperoxia, normoxia |
Primary outcome
Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)
Time frame: 15 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Derived from this study: PubMed 31576438Abou-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama ABOU ARAB, Doctor principal investigator
CHU Amiens-Picardie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing medical oxygen in people with Cardiac Complications, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation) (time frame: 15 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02819739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.