跳至主要内容
临床试验/NCT01329887
NCT01329887已完成3 期

Evaluation of the Effect of Ketanserine on Sublingual Microcirculation by SDF Imaging in Septic Patients on the Intensive Care

Medical Centre Leeuwarden1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

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

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

Other

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

发起方
Medical Centre Leeuwarden
申办方类型
Other
责任方
Principal Investigator
主要研究者

E.C. Boerma

Dr

Medical Centre Leeuwarden

研究点 (1)

Loading locations...

相似试验

The Effect of Ketanserin on the Microcirculation in... | 临床试验