Clinical trial NCT02963454: Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock
Official title: Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Lead sponsor: Military Hospital of Tunis
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Eligibility 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.

Primary outcomes:
measure: changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle
timeFrame: At baseline and then every six hours for the following 72 hours after randomization.
measure: changes in the concentration of lactate(mmol/l) in the extracellular fluid of the skeletal muscle
timeFrame: At baseline and then every six hours for the following 72 hours after randomization.
measure: changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle
timeFrame: At baseline and then every six hours for the following 72 hours after randomization.
measure: changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle
timeFrame: At baseline and then every six hours for the following 72 hours after randomization.
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military Hopital of Tunis
Study officials:
affiliation: Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia
name: mustapha ferhjani
role: STUDY_DIRECTOR
References:
citation: 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.