in this study the investigators aim to assess the role of using dexmedetomidine as sedative in septic shock patients in comparison with midazolam. The investigators aim to assess the effect on immune response and inflammatory mediators and effect on vasopressors.
Sedation protocol All patients will receive analgesia with fentanyl at fixed dose of 0.5 µg.kg.hr-1. Each patient will receive the study drug within 6 hours after ICU admission. Depth of sedation will be assessed using Richmond Agitation and Sedation Scale (RASS) scores (6), which range from -5 (unarousable) to +4 (combative). Study treatments will be infused without loading dose. Group I patients will have dexmedetomidine (4 µg.mL-1) and group II patients will have midazolam (0.33 mg.mL-1). Both drugs will be prepared in 0.9% sodium chloride in 50-mL syringe. Both the agents will be titrated to maintain the RASS in a range of -3 to -1. Dexmedetomidine infusion will be started at 0.1 µg.kg-1.hr-1 and will be adjusted by 0.1 µg.kg-1.h-1 to a maximum of 0.5 µg/kg/h, while midazolam will be started at 1 mg.h-1 (3 mL.hr-1) and adjusted by 1 mg.h-1 to a maximum of 5 mg.h-1 (15 mL.h-1). All infusions will be adjusted by increments of 3 mL/hr-1. Patients in either group not adequately sedated by study drug titration will receive a bolus dose of fentanyl 0.5-1 µg.kg. Assessment of RASS score will be performed every 2 hours and prior to any dose of rescue therapy. The study drugs will be infused for 24 hours and after that the choice of sedation will be determined according to preference of attending physician.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Dexmedetomidine infusion will be started at 0.1 µg.kg-1.hr-1 and will be adjusted by 0.1 µg.kg-1.h-1 to a maximum of 0.5 µg/kg/h,
midazolam will be started at 1 mg.h-1 (3 mL.hr-1) and adjusted by 1 mg.h-1 to a maximum of 5 mg.h-1 (15 mL.h-1).
Kasr Alainy Hospital , Faculty of Medicine
Cairo, Egypt
Change in CD42/CD14
Expression of CD42/CD14 will be measured by flow cytometry
Time frame: 24 hours after start of study drugs infusion
effect on HLA-DR/CD14
Expression of HLA-DR/CD14 will be measured by flow cytometry
Time frame: Baseline before start of drug then 6, 12 and 24 hour after drug
TNFα
Expression of tumor necrosis factor (TNFα) will be measured by flow cytometry
Time frame: Baseline before start of drug then 6, 12 and 24 hour after drug
IL10
Interleukin 10 will be measured by flow cytometry
Time frame: Baseline before start of drug then 6, 12 and 24 hour after drug
KIM-1 level
kidney injury molecule 1
Time frame: Baseline before start of drug and 24 hour after drug
number of participants that will die within 28 days
mortality within 28 days
Time frame: within 28 dyas
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