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

NCT02963454 | Unknown

• 1 other identifier: LEVO02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

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.

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

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.

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

Interventions

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.

dobutamine 5 μg/kg/min; levosimendan 0.2 μg/kg/min

Dobutamine DRUG

Dobutamine (5 μg/kg/min) will be used as indicated

Also known as: DOBUTREX

dobutamine 5 μg/kg/min

Levosimendan DRUG

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

Also known as: SIMDAX

levosimendan 0.2 μg/kg/min

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Military Hospital of Tunis: lead

Study Sites (1)

Military Hopital of Tunis

Tunis, 1008, Tunisia

RECRUITING

Related Publications (1)

• 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.

  PMID: 28234790 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Dobutamine; Simendan

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydrazones; Hydrazines; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• mustapha ferhjani

  Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia

  STUDY DIRECTOR

Central Study Contacts

zied hajjej

CONTACT

20358907; hajjej_zied@hotmail.com

mustapha ferjani

CONTACT

98329256; mustapha.ferjani@planet.tn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 15, 2016
• Study Start: January 1, 2011
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)