The CO2 study: Carbon dioxide insufflation and brain protection during open-heart surgery
- Conditions
- Brain injury following open-heart valve surgerySurgery
- Registration Number
- ISRCTN30671536
- Lead Sponsor
- niversity Hospitals Bristol NHS Foundation Trust
- Brief Summary
2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-074221 (added 18/05/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 530
1. Age = 50 years
2. Planned left side aortic or mitral valve surgical repair or replacement (with or without another procedure, e.g. coronary artery bypass graft) via a partial or full sternotomy using central aortic perfusion cannulae
1. Contraindication to medical carbon dioxide: acquired or genetic of acidosis (i.e. renal tubular acidosis)
2. Contraindication to MRI (e.g. known intolerance, permanent pacemaker in situ or expected implantation of a permanent pacemaker)
3. History of clinical stroke within 3 months prior to randomisation
4. Cardiac catheterisation within 3 days of the planned surgery
5. Cerebral and/or aortic arch arteriography or interventions within 3 days of the planned surgery
6. Active endocarditis at time of randomisation
7. Planned concomitant aortic procedure such as root replacement
8. Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomisation
9. Participation in an interventional (drug or device) trial
10. Unable to provide written informed consent
11. Prisoners
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute ischemic brain injury within 10 days post-surgery based on new brain lesions identified with DW MRI or clinical evidence of permanent brain injury according to the updated definition of stroke for the 21st century
- Secondary Outcome Measures
Name Time Method