临床试验/NCT00569855

NCT00569855已完成2 期

Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery

University of Arkansas1 个研究点分布在 1 个国家目标入组 785 人开始时间: 2001年2月最近更新: 2011年3月1日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: University of Arkansas
入组人数: 785
试验地点: 1
主要终点: Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Cardiopulmonary bypass is done with a machine that does the work of the heart and lungs during open-heart surgery. This study is to determine if intravenous (i.v.) phenoxybenzamine is safe. This drug lowers the blood pressure, making it easier for the cardiopulmonary bypass machine to deliver blood and oxygen to all of the organs and tissues.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: — 至 18 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•0-18 years of age
•weight of less than or equal to 20 kilograms

排除标准

•Parental refusal to give informed consent

研究组 & 干预措施

1

Experimental

Receive phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery

干预措施: Phenoxybenzamine (Drug)

结局指标

主要结局

Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively

时间窗: 72 hours postoperatively

Number of subjects who required Norepinephrine \>0.1mcq/kg/min

次要结局

未报告次要终点

研究者

发起方

University of Arkansas

申办方类型

Other

研究点 (1)

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