Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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: Levosimendan
Levosimendan (0.2 μg/kg/min) will be used as indicated
Other Names:
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| Active Comparator: 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. |
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:
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Outcome Measures
Primary Outcome Measures
- 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 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 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.]
- 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.]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Military Hopital of Tunis | Tunis | Tunisia | 1008 |
Sponsors and Collaborators
- Military Hospital of Tunis
Investigators
- Study Director: mustapha ferhjani, Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LEVO02