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临床试验/NCT03144258
NCT03144258已完成不适用

Evaluation of the Systemic Microcirculation in the Course of Cardiopulmonary Bypass Used in the Surgery for Repair of Congenital Heart Defects in Infants and Children

National Institute of Cardiology, Laranjeiras, Brazil1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Microcirculatory alterations during cardiopulmonary bypass

研究概览

简要总结

General objective of the research project: To evaluate the alterations of systemic microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to cardiac surgery for repair of congenital heart defects.

详细描述

• Specific objectives:

  • To test the usefulness of skin laser Doppler flowmetry monitoring (LDPM) in the non-invasive evaluation of endothelium-dependent microvascular reactivity during CPB in children.
  • To investigate whether skin LDPM could be proposed as a clinical monitoring of tissue perfusion during CPB in pediatric cardiac surgery.
  • To investigate the effects of different anesthetic agents on microvascular reactivity during CPB.
  • To investigate the effects of cardiovascular and vasoactive drugs used during CPB on microvascular reactivity.
  • To evaluate the correlation of microcirculatory alterations observed during CPB with classical markers of tissue perfusion and oxygenation, including plasma lactate levels.
  • To evaluate the correlation of microcirculatory alterations observed during CPB with markers of systemic inflammation, including pro- and anti-inflammatory cytokines.
  • To evaluate the correlation of microcirculatory alterations observed during CPB with the plasma bioavailability of nitric oxide.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • infants and children with congenital heart defects scheduled to corrective cardiac surgery

排除标准

  • age inferior to 3 months and superior to 6 years

结局指标

主要结局

Microcirculatory alterations during cardiopulmonary bypass

时间窗: december 2019

Evaluation of the alterations of microcirculatory parameters and tissue perfusion during cardiopulmonary bypass in children submitted to cardiac corrective surgery for congenital heart defects

次要结局

未报告次要终点

研究者

发起方
National Institute of Cardiology, Laranjeiras, Brazil
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eduardo Tibirica, MD, PhD

Senior Researcher

National Institute of Cardiology, Laranjeiras, Brazil

研究点 (1)

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