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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microdialysis Probe (Muscle microdialysis) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zied hajjej | Contact | 20358907 | hajjej_zied@hotmail.com | |
| mustapha ferjani | Contact | 98329256 | mustapha.ferjani@planet.tn |
| Name | Affiliation | Role |
|---|---|---|
| mustapha ferhjani | Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military Hopital of Tunis | Recruiting | Tunis | 1008 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28234790 | Derived | Hajjej Z, Meddeb B, Sellami W, Labbene I, Morelli A, Ferjani M. Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock: A Randomized Controlled Pilot Study. Shock. 2017 Sep;48(3):307-312. doi: 10.1097/SHK.0000000000000851. |
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via emails
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D004280 | Dobutamine |
| D000077464 | Simendan |
| ID | Term |
|---|---|
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
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|
| Dobutamine | Drug | Dobutamine (5 μg/kg/min) will be used as indicated |
|
|
| Levosimendan | Drug | Levosimendan (0.2 μg/kg/min) will be used as indicated |
|
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D005021 |
| Ethylamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D011724 | Pyridazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |