Status:
UNKNOWN
Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients
Lead Sponsor:
Military Hospital of Tunis
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
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 septi...
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 loca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03434691
Start Date
February 8 2018
End Date
December 31 2018
Last Update
February 15 2018
Active Locations (2)
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1
Military hospital of tunis
Tunis, Mont Fleury, Tunisia, 1008
2
Military Hopital of Tunis
Tunis, Tunisia, 1008