The Effect of Early Goal Directed Sedation on Microcirculation in Septic Shock Patients With Mechanical Ventilation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Microcirculatory function as assessed by perfused vessel density
研究概览
简要总结
The investigators will conduct a prospective, single-center, randomized, double-blinded, controlled study to investigate the effect of early goal directed sedation on microcirculation in early septic shock patients.
详细描述
Recent studies suggest that early goal directed sedation might improve the outcome of critically ill patients. The investigators will conduct a prospective, single-center, randomized, double-blinded, controlled study to investigate the effect of early goal directed sedation on microcirculation in early septic shock patients with relative stable hemodynamics.
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 —（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
- •Required sedation
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
Early goal directed sedation group
Dexmedetomidine for sedation in early goal directed sedation group
- Analgesia
- Dexmedetomidine start at 0.7ug/kg/hour
- Dose range: 0.2- 0.7 u/kg/hour
- Supplemental other sedatives at lowest effective dose Target Richmond Agitation-Sedation Scale score of -2 to +1 to achieve sedation goal in EGDS group
干预措施: Dexmedetomidine for sedation (Drug)
Standard sedation
Control drug for sedation in early goal directed sedation group
- Analgesia
- Control drug
- Supplemental other sedatives at lowest effective dose for standard sedation Target Richmond Agitation-Sedation Scale score of -2 to +1 to achieve sedation goal
干预措施: Dexmedetomidine for sedation (Drug)
结局指标
主要结局
Microcirculatory function as assessed by perfused vessel density
时间窗: one hour
Microcirculatory parameter
次要结局
- Dose of sedatives and analgesic agents(14 days)
- Oxygen metabolic: lactate clearance time(six hours)
研究者
Jingyuan,Xu
Principal investigator
Southeast University, China