The Effect of Dexmedetomidine on Perfusion Index and Microcirculation in Patients With Severe Sepsis and Septic Shock: Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 主要终点
- Evaluation of microvascular flow index 6hours after dexmedetomidine infusion
研究概览
简要总结
Septic shock is one of the major causes of death worldwide with in-hospital mortality rates varying between (11.9% to 47.2 %). Alterations in microcirculatory blood flow were associated with high risk of organ dysfunction and death. Experimental studies on septic rats revealed that dexmedetomidine treatment can effectively reduce the generation of inflammatory mediators and yields beneficial effects on endotoxemic animals' microcirculation.
详细描述
Prospective randomized double blinded study. Investigators planned to enroll (40 cases diagnosed with severe sepsis and/or septic shock ) admitted in 50-bed trauma and surgical ICU Cairo University hospital. Demographic data, cause of ICU admission, source of sepsis, APACHE II score, SOFA score 24 hours after admission. Microcirculatory variables (MFI), peripheral perfusion (PI) and metabolic variables will be measured before drugs administrations and at 2, 4, 6, 24 hours thereafter. The total dose of the infused drugs, The requirement of vasopressor will be evaluated as yes/no and total dose of vasopressor will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
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
- •Age more than 18 years old
- •All mechanically ventilated patients who will be clinically suspected of having severe sepsis/septic shock defined by the criteria of the American College of Chest Physicians/ Society of Critical Care Medicine Consensus Conference
排除标准
- •Age < 18 years old
- •Pregnant patient
- •Acute hepatitis or severe liver disease (Child-Pugh class C)
- •Left ventricular ejection fraction less than 30%
- •Heart rate less than 50 beats/min
- •Second or third degree heart block
- •Systolic pressure < 90 mmHg despite of infusion of 2 vasopressors
研究组 & 干预措施
Dexmedetomidin
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Evaluation of microvascular flow index 6hours after dexmedetomidine infusion
时间窗: 6 months
次要结局
- Correlation between perfusion index and microvascular flow index in septic shock patients(6 months)
- The effect of the dexmeditomidine on perfusion index(6 months)
研究者
Islam Rasmy
Assisstant lecturer
Cairo University