Trial | NCT02963454  Report issue

Title

Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock
Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock: A Randomised Controlled Study

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    levosimendan dobutamine ...

  • Study Participants

    50
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.
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.
Study Started
Jan 31
2011
Primary Completion
Feb 28
2018
Anticipated
Study Completion
Feb 28
2018
Anticipated
Last Update
Feb 12
2018

Device Microdialysis Probe (Muscle microdialysis)

Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were determined at baseline and then every six hours for the following 72 hours after randomization. During the study period, conventional treatment was continued as per usual practice. Fluid challenges were performed, and repeated as necessary, to maintain central venous pressure (CVP) ≥8 and pulmonary arterial occlusion pressure (PAOP) ≥12 mmHg. Norepinephrine was titrated to maintain mean arterial pressure (MAP) ≥65 mmHg. Packed red blood cells were transfused when Hemoglobin (Hb) concentrations decreased below 7 g/dL, or if the patient exhibited clinical signs of inadequate systemic oxygen supply.

Drug Dobutamine

Dobutamine (5 μg/kg/min) will be used as indicated

  • Other names: DOBUTREX

Drug Levosimendan

Levosimendan (0.2 μg/kg/min) will be used as indicated

  • Other names: SIMDAX

levosimendan 0.2 μg/kg/min Experimental

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 Active Comparator

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.

Criteria 

Inclusion Criteria:

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)

Exclusion Criteria:

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.
No Results Posted