Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients

Military Hospital of Tunis

Status: Unknown

Conditions: Septic Shock

Treatments: Device: Microdialysis Probe (Muscle microdialysis); Drug: remifentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03434691

DEX03/06

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 Dexmedetomidine administration in patients with septic shock.

Full description

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

DEX group

Experimental group

Description:

continuous infusion of Dexmedetomidine at 0.4 μg/kg per hour and remifentanyl A microdialysis probe was placed into the femoral quadriceps. An initial set of measurements will be obtained during the sedation with Midazolam and remifentanyl (before randomization). This set of measurements will be considered as baseline. Then samples were collected every 6 hours for 3 days. The changes in the energy-related metabolites lactate, the lactate/pyruvate ratio, glucose and glycerol were analyzed. Concomitantly with dialysate sampling, the effects on global haemodynamics, were assessed. Lactate and L/P clearances were also calculated.

Treatment:

Device: Microdialysis Probe (Muscle microdialysis)

Drug: remifentanyl

MDZ group

Active Comparator group

Description:

continuous infusion of a Midazolam at 0,1 mg/kg/h and remifentanyl A microdialysis probe was placed into the femoral quadriceps. An initial set of measurements will be obtained during the sedation with Midazolam and remifentanyl (before randomization). This set of measurements will be considered as baseline. Then samples were collected every 6 hours for 3 days. The changes in the energy-related metabolites lactate, the lactate/pyruvate ratio, glucose and glycerol were analyzed. Concomitantly with dialysate sampling, the effects on global haemodynamics, were assessed. Lactate and L/P clearances were also calculated.

Treatment:

Device: Microdialysis Probe (Muscle microdialysis)

Drug: remifentanyl