Brain injury following open-heart valve surgery Surgery
Conditions
Interventions
Participants will be randomised in a 1:1 ratio (stratified by type or procedure and centre) to receive either carbon dioxide insufflation (IMP) or medical air insufflation (placebo).
Insufflation wit
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Number and volume of DWI brain lesions measured using the DW MRI conducted for each participant between 2-10 days post-surgery 2. Objective quantification of the impairment caused by new ischemic brain injury assessed using the National Institutes of Health Stroke Scale at pre-surgery, day 3 and three months post-surgery 3. Delirium assessed using the 3-minute diagnostic interview for Confusion Assessment Method at pre-surgery, day 3 and three months post-surgery 4. Functional status assessed using the Barthel Index score at pre-surgery and three months post-surgery 5. Neurocognitive function assessed at pre-surgery and three months post-surgery using the following tests: 5.1. Addenbrooke’s Cognitive Examination III 5.2. Trail making Tests A and B 6. Quality of life assessed using the 12-Item Short-Form Health Survey (SF-12) at pre-surgery and three months post-surgery 7. Composite of all-cause mortality, clinical stroke, or acute kidney injury within 30 days of surgery, by review of participants medical notes 8. Serious adverse events (SAEs) to 3 months, by review of participants medical notes and discussion with the participant at the three month post-surgery follow up visit 9. Survival to 3 months by review of the participants medical notes and attendance at the three-month post-surgery follow up visit | — |
Countries
England, United Kingdom
Contacts
Public ContactLucy Hamilton
Outcome results
None listed