ISRCTN30671536进行中（未招募）3 期
Carbon dioxide insufflation and brain protection during open-heart surgery: a randomised controlled trial
niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 530 人开始时间: 2020年7月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 530
研究概览
简要总结
2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-074221 (added 18/05/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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