Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock: A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- changes in the concentration of glycerol (µmol/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 levosimendan administration in patients with septic shock.
详细描述
The study was designed as a prospective, double-blind, controlled, clinical trial and performed in a multidisciplinary intensive care unit. After achieving normovolemia and a mean arterial pressure of at least 65 mmHg, 20 septic shock patients were randomized to receive either levosimendan 0.2 μg/kg/min, or dobutamine 5 μg/kg/min. Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained by using muscle microdialysis. All measurements, including data from right heart catheterization were obtained at baseline and every 6 hours for the following 72 hours after randomization.
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
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who fulfilled the criteria of septic shock that required norepinephrine (NE) to maintain a mean arterial pressure (MAP) of at least 65 mm Hg despite appropriate volume resuscitation (pulmonary arterial occlusion pressure [PAOP] = 12 to 18 mm Hg and central venous pressure [CVP] = 8 to 12 mm Hg)
排除标准
- •pregnancy, uncontrolled hemorrhage, terminal heart failure, significant valvular heart disease, documented or suspected acute coronary syndrome, and a limitation on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve.
研究组 & 干预措施
levosimendan 0.2 μg/kg/min
Treatment with levosimendan 0.2 μg/kg/min 24h (without bolus).
Muscle microdialysis was performed using a microdialysis probe inserted into the quadriceps femoris muscle.
干预措施: Microdialysis Probe (Muscle microdialysis) (Device)
levosimendan 0.2 μg/kg/min
Treatment with levosimendan 0.2 μg/kg/min 24h (without bolus).
Muscle microdialysis was performed using a microdialysis probe inserted into the quadriceps femoris muscle.
干预措施: Levosimendan (Drug)
dobutamine 5 μg/kg/min
Treatment with dobutamine 5 μg/kg/min. Dobutamine were administered during all the 72 hours study period.
Muscle microdialysis was performed using a microdialysis probe inserted into the quadriceps femoris muscle.
干预措施: Microdialysis Probe (Muscle microdialysis) (Device)
dobutamine 5 μg/kg/min
Treatment with dobutamine 5 μg/kg/min. Dobutamine were administered during all the 72 hours study period.
Muscle microdialysis was performed using a microdialysis probe inserted into the quadriceps femoris muscle.
干预措施: Dobutamine (Drug)
结局指标
主要结局
changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle
时间窗: At baseline and then every six hours for the following 72 hours after randomization.
changes in the concentration of lactate(mmol/l) in the extracellular fluid of the skeletal muscle
时间窗: At baseline and then every six hours for the following 72 hours after randomization.
changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle
时间窗: At baseline and then every six hours for the following 72 hours after randomization.
changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle
时间窗: At baseline and then every six hours for the following 72 hours after randomization.
次要结局
未报告次要终点
研究者
Hajjej Zied
Doctor
Military Hospital of Tunis