Evaluation of the Effect of Ketanserine on Sublingual Microcirculation by SDF Imaging in Septic Patients on the Intensive Care
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- microcirculation
研究概览
简要总结
This study is an evaluation of the effect of ketanserine on sublingual microcirculation in intensive care patients with severe sepsis.
详细描述
This is a pilot study, including 10 ICU patients with severe sepsis with MFI < 2,5 after fulfillment of a strict resuscitation protocol. At the start of the study, a baseline SDF measurement is made, when MFI < 2,5 inclusion in the study is permitted and intravenous ketanserin administration is started and subsequently increased, guided by the effect on sublingual MFI, until a safe maximum dosage is reached. Safety margins for hypotension are defined in the study protocol.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe sepsis and MFI < 2,5 after resuscitation
排除标准
- •age < 18 year old
- •participation other trials prolonged Qt interval
研究组 & 干预措施
administration of ketanserin
干预措施: ketanserin (Drug)
结局指标
主要结局
microcirculation
时间窗: 2 hours
achievement of a microvascular flow index \>2,9
次要结局
- ketanserine dosage(48 hours)
研究者
E.C. Boerma
Dr
Medical Centre Leeuwarden
