Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock
- Conditions
- Septic Shock
- Interventions
- Registration Number
- NCT02963454
- Lead Sponsor
- Military Hospital of Tunis
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description levosimendan 0.2 μg/kg/min Microdialysis Probe (Muscle microdialysis) 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. dobutamine 5 μg/kg/min Microdialysis Probe (Muscle microdialysis) 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. levosimendan 0.2 μg/kg/min Levosimendan 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. dobutamine 5 μg/kg/min Dobutamine 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.
- Primary Outcome Measures
Name Time Method changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle 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 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 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 At baseline and then every six hours for the following 72 hours after randomization.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Military Hopital of Tunis
🇹🇳Tunis, Tunisia