Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock

Military Hospital of Tunis

Status: Unknown

Conditions: Septic Shock

Treatments: Drug: Levosimendan; Drug: Dobutamine; Device: Microdialysis Probe (Muscle microdialysis)

Study type: Interventional

Funder types: Other

Identifiers

NCT02963454

LEVO02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 16 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

levosimendan 0.2 μg/kg/min

Experimental group

Description:

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.

Treatment:

Device: Microdialysis Probe (Muscle microdialysis)

Drug: Levosimendan

dobutamine 5 μg/kg/min

Active Comparator group

Description:

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.

Treatment:

Drug: Dobutamine

Device: Microdialysis Probe (Muscle microdialysis)