The Effect of Dexmedetomidine on Microcirculation in Septic Shock- A Double-blinded Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Microcirculatory function as assessed by Microvascular flow index
研究概览
简要总结
The investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. To test this effect, the investigators will conduct double-blinded study.
详细描述
Dexmedetomidine is a highly selective α2-adrenoreceptor agonist for sedation of adult critically ill patients which exhibits sedative and analgesic effects. Recent studies suggest that dexmedetomidine to restore adrenergic vasoconstrictor responsiveness in septic shock, and prevents alterations of pain rat model intestinal microcirculation Induced by surgical stress，even it can reduce the mortality of endotoxemic rats and patients with severe sepsis. The investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. To test this effect, the investigators will conduct double-blinded study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic shock patients despite early goal directed therapy
- •Agree to participate this study
排除标准
- •Pregnancy
- •Bradycardia (HR<55bpm)
- •Systolic Blood Pressure < 80 mmHg / Mean arterial pressure < 50 mmHg on maximal support
- •Death imminent
- •Unlikely to survive 90 days
- •Acute liver failure
- •High-grade block in the absence of a functioning pacemaker.
研究组 & 干预措施
Dexmedetomidine group
Dexmedetomidine group: Dexmedetomidine infusion for dexmedetomidine group to the goal of sedation: Richmond agitation-sedation scale 0 to -2 Dexmedetomidine doses 0-0.7 mcg/kg/h
干预措施: Dexmedetomidine for dexmedetomidine group (Drug)
Control group
Control group: Placebo infusion for control group to the goal of sedation: Richmond agitation-sedation scale 0 to -2 Control drug doses 0-0.7 mcg/kg/h
干预措施: Dexmedetomidine for dexmedetomidine group (Drug)
结局指标
主要结局
Microcirculatory function as assessed by Microvascular flow index
时间窗: 30 minutes
sedation for 30 minutes then monitor the microcirculation
次要结局
未报告次要终点
研究者
Jingyuan,Xu
Principal investigator
Southeast University, China