Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients: a Muscle Microdialysis Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle
研究概览
简要总结
To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the extracellular fluid of the skeletal muscle following Dexmedetomidine administration in patients with septic shock.
详细描述
Prospective randomized double blinded study. Investigators planned to enroll 60 cases diagnosed with septic shock All patients will be sedated with Midazolam and remifentanyl in accordance with a local unit protocol.
After a period of six hours of hemodynamic stability, patients were randomized to receive either continuous infusion of Dexmedetomidine at 0.4 μg/kg per hour and remifentanyl (DEX group) or a continuous infusion of a Midazolam and remifentanyl (MDZ Group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (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
- •Patients aged over 18 years
- •Septic shock requiring norepinephrine (NE) to maintain a mean arterial pressure (MAP) of at least 65mm Hg despite appropriate volume resuscitation (fluid challenge of 20 mL/kg-40 mL/kg)
- •Septic shock criteria were defined according to the new Sepsis-3 definition
排除标准
- •pregnancy
- •uncontrolled hemorrhage
- •terminal heart failure
- •significant valvular heart disease
- •documented or suspected acute coronary syndrome, and limitations on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve
- •refractory bradycardia (heart rate slower than 60 bpm despite of adequate treatment)
- •2nd and 3rd degree of AV-block ,the onset of septic shock more than 24 h before enrollment ,
- •APACHE II > 30 at enrollment
- •Severe liver cirrhosis (Child B or C)
- •New onset of myocardial infarction within 30 days or heart failure (NYHA 4)
- •attending other trial in ICU within one month
- •allergic history to dexmedetomidine
研究组 & 干预措施
DEX group
continuous infusion of Dexmedetomidine at 0.4 μg/kg per hour and remifentanyl A microdialysis probe was placed into the femoral quadriceps. An initial set of measurements will be obtained during the sedation with Midazolam and remifentanyl (before randomization). This set of measurements will be considered as baseline. Then samples were collected every 6 hours for 3 days. The changes in the energy-related metabolites lactate, the lactate/pyruvate ratio, glucose and glycerol were analyzed. Concomitantly with dialysate sampling, the effects on global haemodynamics, were assessed. Lactate and L/P clearances were also calculated.
干预措施: Microdialysis Probe (Muscle microdialysis) (Device)
DEX group
continuous infusion of Dexmedetomidine at 0.4 μg/kg per hour and remifentanyl A microdialysis probe was placed into the femoral quadriceps. An initial set of measurements will be obtained during the sedation with Midazolam and remifentanyl (before randomization). This set of measurements will be considered as baseline. Then samples were collected every 6 hours for 3 days. The changes in the energy-related metabolites lactate, the lactate/pyruvate ratio, glucose and glycerol were analyzed. Concomitantly with dialysate sampling, the effects on global haemodynamics, were assessed. Lactate and L/P clearances were also calculated.
干预措施: remifentanyl (Drug)
MDZ group
continuous infusion of a Midazolam at 0,1 mg/kg/h and remifentanyl A microdialysis probe was placed into the femoral quadriceps. An initial set of measurements will be obtained during the sedation with Midazolam and remifentanyl (before randomization). This set of measurements will be considered as baseline. Then samples were collected every 6 hours for 3 days. The changes in the energy-related metabolites lactate, the lactate/pyruvate ratio, glucose and glycerol were analyzed. Concomitantly with dialysate sampling, the effects on global haemodynamics, were assessed. Lactate and L/P clearances were also calculated.
干预措施: Microdialysis Probe (Muscle microdialysis) (Device)
MDZ group
continuous infusion of a Midazolam at 0,1 mg/kg/h and remifentanyl A microdialysis probe was placed into the femoral quadriceps. An initial set of measurements will be obtained during the sedation with Midazolam and remifentanyl (before randomization). This set of measurements will be considered as baseline. Then samples were collected every 6 hours for 3 days. The changes in the energy-related metabolites lactate, the lactate/pyruvate ratio, glucose and glycerol were analyzed. Concomitantly with dialysate sampling, the effects on global haemodynamics, were assessed. Lactate and L/P clearances were also calculated.
干预措施: remifentanyl (Drug)
结局指标
主要结局
changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle
时间窗: Time Frame: At baseline and then every six hours for the following 72 hours after randomization
collected every 6 hours for 3 days
changes in the concentration of lactate(mmol/l) in the extracellular fluid of the skeletal muscle
时间窗: Time Frame: At baseline and then every six hours for the following 72 hours after randomization
collected every 6 hours for 3 days
changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle
时间窗: Time Frame: At baseline and then every six hours for the following 72 hours after randomization
collected every 6 hours for 3 days
changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle
时间窗: Time Frame: At baseline and then every six hours for the following 72 hours after randomization
collected every 6 hours for 3 days
次要结局
未报告次要终点
研究者
Hajjej Zied
Clinical Professor
Military Hospital of Tunis