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

Septic Shock Clinical Trial

Official title:

Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock: A Randomised Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02963454
• Other study ID #: LEVO02
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2016
• Last updated: February 8, 2018
• Start date: January 2011
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: Military Hospital of Tunis
• Contact: zied hajjej
• Phone: 20358907
• Email: hajjej_zied[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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
• Levosimendan
Levosimendan (0.2 µg/kg/min) will be used as indicated

Locations

Country	Name	City	State
Tunisia	Military Hopital of Tunis	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Military Hospital of Tunis

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.