The Management of Systemic-Pulmonary Collateral Blood Flow in Cyanotic Children During Cardiopulmonary Bypass - Pilot Study
The purpose of the study is to determine whether it is possible to manage the flow of blood through blood vessels using varying levels of carbon dioxide during cardiac surgery, and what effect this has on how well the major organs of the body work.
研究概览
详细说明
A great number of studies have shown that MAPCAs are a real issue for these patients, who require far higher blood flows than previously suggested.
However, the optimal method of CPB is still unknown.
Recent research by Sakamoto et al., showed that a raised carbon dioxide (pCO2) increased brain blood flow in cyanotic patients, suggesting a noticeable decrease in aorto-pulmonary blood shunting.
However, the mechanism of this action is not understood and it is unclear if this observation is an associated or causative one.
Whilst the vasoconstrictive (narrowing of vessels) effect of hypoxia has been well documented, with and without high carbon dioxide, there are no reports indicating that pCO2 alone increases the narrowing of blood vessels in the lung.
We hypothesize that a rise in pCO2 could cause a shift in blood flow from pulmonary to systemic circulation, either through direct constricting action on MAPCA vessels, or through a vasoconstriction of blood vessels in the lung.
Furthermore, we predict the phenomenon could potentially be used to optimize the method of treatment, ensuring that vital organs receive the correct amount of blood flow during the surgical correction of these rare congenital heart diseases.
研究类型
介入性
注册 (预期的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Richard W Issitt
- 电话号码:0044 (0) 278138287
- 邮箱:richard.issitt@gosh.nhs.uk
学习地点
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London、英国、WC1N 3JH
- 招聘中
- Great Ormond Street Hospital
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接触:
- Ricahrd Issitt
- 电话号码:02078138287
- 邮箱:richard.issitt@gosh.nhs.uk
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1天 至 5年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients whose parents/guardians are willing and able to provide written informed consent for participation in the study
- Patients undergoing elective TCPC surgery
- MRI proven presence of MAPCA vessels
- Patients between 1 day and 5 years of age
Exclusion Criteria:
- Emergency surgery
- Documented history of cognitive impairment (may have an effect on biochemical markers of cerebral injury)
- Documented history of major organ dysfunction
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:Alpha Stat
Standard CPB blood gas management conditions
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实验性的:pH Stat
pH stat blood gas management conditions.
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pH stat blood gas management - increased carbon dioxide content of administered gas mixture.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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MAPCA Flow
大体时间:During surgery
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To determine the optimal conditions for treating cyanotic patients with MAPCAs on CPB
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During surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Maximum levels of Biochemical markers of Cerebral and Tissue Injury, as measure by Neurone-Specific Enolase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase and Near Infrared Spectroscopy
大体时间:3 days Post Surgical Period
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To determine if increased pCO2 levels results in altered organ and tissue perfusion as measure by Neurone-Specific Enolase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase and Near Infrared Spectroscopy
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3 days Post Surgical Period
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Richard W Issitt、Great Ormond Street Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Whitehead KK, Gillespie MJ, Harris MA, Fogel MA, Rome JJ. Noninvasive quantification of systemic-to-pulmonary collateral flow: a major source of inefficiency in patients with superior cavopulmonary connections. Circ Cardiovasc Imaging. 2009 Sep;2(5):405-11. doi: 10.1161/CIRCIMAGING.108.832113. Epub 2009 Jul 8. Erratum In: Circ Cardiovasc Imaging. 2010 Jan;3(1):e1.
- Fujii Y, Kotani Y, Kawabata T, Ugaki S, Sakurai S, Ebishima H, Itoh H, Nakakura M, Arai S, Kasahara S, Sano S, Iwasaki T, Toda Y. The benefits of high-flow management in children with pulmonary atresia. Artif Organs. 2009 Nov;33(11):888-95. doi: 10.1111/j.1525-1594.2009.00895.x. Epub 2009 Oct 10.
- Haworth SG, Macartney FJ. Growth and development of pulmonary circulation in pulmonary atresia with ventricular septal defect and major aortopulmonary collateral arteries. Br Heart J. 1980 Jul;44(1):14-24. doi: 10.1136/hrt.44.1.14. No abstract available.
- Liao PK, Edwards WD, Julsrud PR, Puga FJ, Danielson GK, Feldt RH. Pulmonary blood supply in patients with pulmonary atresia and ventricular septal defect. J Am Coll Cardiol. 1985 Dec;6(6):1343-50. doi: 10.1016/s0735-1097(85)80223-0.
- Baile EM, Ling H, Heyworth JR, Hogg JC, Pare PD. Bronchopulmonary anastomotic and noncoronary collateral blood flow in humans during cardiopulmonary bypass. Chest. 1985 Jun;87(6):749-54. doi: 10.1378/chest.87.6.749.
- Sakamoto T, Kurosawa H, Shin'oka T, Aoki M, Isomatsu Y. The influence of pH strategy on cerebral and collateral circulation during hypothermic cardiopulmonary bypass in cyanotic patients with heart disease: results of a randomized trial and real-time monitoring. J Thorac Cardiovasc Surg. 2004 Jan;127(1):12-9. doi: 10.1016/j.jtcvs.2003.08.033.
- Kato M, Staub NC. Response of small pulmonary arteries to unilobar hypoxia and hypercapnia. Circ Res. 1966 Aug;19(2):426-40. doi: 10.1161/01.res.19.2.426. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年3月1日
初级完成 (预期的)
2017年7月1日
研究注册日期
首次提交
2014年11月26日
首先提交符合 QC 标准的
2015年2月6日
首次发布 (估计)
2015年2月9日
研究记录更新
最后更新发布 (估计)
2016年8月23日
上次提交的符合 QC 标准的更新
2016年8月22日
最后验证
2016年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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