Clinical trial NCT03434691: Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients
Official title: Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients: a Muscle Microdialysis Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Lead sponsor: Military Hospital of Tunis
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: 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 Dexmedetomidine administration in patients with septic shock.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle
timeFrame: Time Frame: 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: Time Frame: 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: Time Frame: 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: Time Frame: 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 hospital of tunis
state: Mont Fleury
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 Ferjani
role: STUDY_DIRECTOR
References: