Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients

Military Hospital of Tunis40 enrolled

Overview

To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the extracellular fluid of the skeletal muscle following Dexmedetomidine administration in patients with septic shock.

Prospective randomized double blinded study. Investigators planned to enroll 60 cases diagnosed with septic shock All patients will be sedated with Midazolam and remifentanyl in accordance with a local unit protocol. After a period of six hours of hemodynamic stability, patients were randomized to receive either continuous infusion of Dexmedetomidine at 0.4 μg/kg per hour and remifentanyl (DEX group) or a continuous infusion of a Midazolam and remifentanyl (MDZ Group).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Enrollment

Conditions

Septic Shock

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.

remifentanylDRUG

Only the dose of remifentanyl (initial infusion of 6 µg/kg/h) can be changed to achieve a Goal of sedation: Richmond agitation-sedation scale 0 to -2.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged over 18 years * Septic shock requiring norepinephrine (NE) to maintain a mean arterial pressure (MAP) of at least 65mm Hg despite appropriate volume resuscitation (fluid challenge of 20 mL/kg-40 mL/kg) * Septic shock criteria were defined according to the new Sepsis-3 definition Exclusion Criteria: * pregnancy * uncontrolled hemorrhage * terminal heart failure * significant valvular heart disease * documented or suspected acute coronary syndrome, and limitations on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve * refractory bradycardia (heart rate slower than 60 bpm despite of adequate treatment) * 2nd and 3rd degree of AV-block ,the onset of septic shock more than 24 h before enrollment , * APACHE II \> 30 at enrollment * Severe liver cirrhosis (Child B or C) * New onset of myocardial infarction within 30 days or heart failure (NYHA 4) * attending other trial in ICU within one month * allergic history to dexmedetomidine

Locations (2)

Military hospital of tunis

Tunis, Mont Fleury, Tunisia

RECRUITING

Military Hopital of Tunis

Tunis, Tunisia

RECRUITING

Outcomes

Primary Outcomes

changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle

collected every 6 hours for 3 days

Time frame: Time Frame: 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

collected every 6 hours for 3 days

Time frame: Time Frame: 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

collected every 6 hours for 3 days

Time frame: Time Frame: 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

collected every 6 hours for 3 days

Time frame: Time Frame: At baseline and then every six hours for the following 72 hours after randomization

Central Contacts

Zied Hajjej

CONTACT

0021620358907 hajjej_zied@hotmail.com

Data from ClinicalTrials.gov

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