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临床试验/NCT02358382
NCT02358382Unknown不适用

The Management of Systemic-Pulmonary Collateral Blood Flow in Cyanotic Children During Cardiopulmonary Bypass - Pilot Study

Great Ormond Street Hospital for Children NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
MAPCA Flow

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Day 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Emergency surgery
  • Documented history of cognitive impairment (may have an effect on biochemical markers of cerebral injury)
  • Documented history of major organ dysfunction

研究组 & 干预措施

pH Stat

Experimental

pH stat blood gas management conditions.

干预措施: pH Stat (Drug)

结局指标

主要结局

MAPCA Flow

时间窗: During surgery

To determine the optimal conditions for treating cyanotic patients with MAPCAs on CPB

次要结局

  • 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(3 days Post Surgical Period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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