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临床试验/NCT03678909
NCT03678909已完成不适用

Cardiac Biomarkers in Patients With Single Ventricle Physiology

Baylor College of Medicine1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Mortality

研究概览

简要总结

All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.

These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

详细描述

All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.

These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

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
— 至 2 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Hypoplastic Left Heart Syndrome as congenital heart disease as a neonate

排除标准

  • Other diagnosis of congenital heart disease than Hypoplastic Left Heart Syndrome Patients older than 30 days

结局指标

主要结局

Mortality

时间窗: 3- 6 months depending on second stage procedure

Mortality up to anticipated Glenn Procedure

次要结局

  • NEC(3- 6 months depending on second stage procedure)
  • Reintubation(3- 6 months depending on second stage procedure)
  • Cath intervention(3- 6 months depending on second stage procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Anders

Assistant Professor

Baylor College of Medicine

研究点 (1)

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