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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
50
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.
Dobutamine (5 μg/kg/min) will be used as indicated
Military Hopital of Tunis
Tunis, Tunisia
RECRUITINGchanges in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle
Time frame: 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
Time frame: 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
Time frame: At baseline and then every six hours for the following 72 hours after randomization.
changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle
Time frame: At baseline and then every six hours for the following 72 hours after randomization.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Levosimendan (0.2 μg/kg/min) will be used as indicated