The goal of this clinical trial is to learn whether early administration of dexmedetomidine can improve autonomic nervous system regulation and clinical outcomes in adult patients with septic shock. It will also evaluate the safety of dexmedetomidine in this population. The main questions it aims to answer are: Does early dexmedetomidine improve sympathetic nervous system activity, as measured by heart rate variability (HRV) and blood pressure variability (BPV)? Does dexmedetomidine reduce endogenous catecholamine levels and vasopressor requirements? Does early autonomic modulation improve organ function and survival outcomes in septic shock? Researchers will compare dexmedetomidine to a placebo (normal saline) to determine whether dexmedetomidine improves hemodynamic stability and prognosis in patients with septic shock. Participants will: Be randomly assigned to receive dexmedetomidine (0.5 μg/kg/h) or placebo by continuous intravenous infusion for 48 hours Undergo continuous ECG and invasive blood pressure monitoring Have blood samples collected at predefined time points to measure inflammatory markers and endogenous catecholamine levels Be assessed for organ function, vasopressor use, and perfusion parameters during the first 48 hours Be followed up for 28-day and 90-day survival outcomes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
168
0.5 micrograms per kilogram per hour (0.5 μg/kg/h)
0.9% Sodium Chloride Injection
Heart Rate Variability (HRV)
Heart rate variability will be assessed using continuous electrocardiographic monitoring. The primary HRV parameter analyzed will be the standard deviation of normal-to-normal intervals (SDNN).
Time frame: From enrollment to the end of treatment at 48 hours
Change in Sequential Organ Failure Assessment (SOFA) Score
The change in Sequential Organ Failure Assessment (SOFA) score from baseline to 48 hours will be used to evaluate organ dysfunction.
Time frame: From enrollment to the end of treatment at 48 hours
Interleukin-6 (IL-6) level
Change in plasma IL-6 levels from baseline to 48 hours
Time frame: From enrollment to the end of treatment at 48 hours
ICU length of stay
Duration of ICU stay for each participant
Time frame: From enrollment to ICU discharge or 90 days, whichever occurs first
Duration of Mechanical Ventilation
Total duration of invasive mechanical ventilation during the first 48 hours after enrollment.
Time frame: From randomization until successful liberation from mechanical ventilation, assessed up to 28 days.
Requirement for Renal Replacement Therapy (RRT)
Number of participants requiring renal replacement therapy during the first 48 hours after enrollment.
Time frame: From randomization to 28 days after randomization.
Tumor necrosis factor-α (TNF-α) level
Change in plasma TNF-α levels from baseline to 48 hours
Time frame: From enrollment to the end of treatment at 48 hours
Procalcitonin (PCT) clearance
Percentage change in PCT levels relative to baseline
Time frame: From enrollment to the end of treatment at 48 hours
28-day all-cause mortality
Proportion of participants who die from any cause within 28 days of enrollment
Time frame: From enrollment to 28 days
90-day all-cause mortality
Proportion of participants who die from any cause within 90 days of enrollment
Time frame: From enrollment to 90 days
Incidence of new-onset organ dysfunction
Number of participants developing new organ dysfunction during the study period
Time frame: From enrollment to 90 days or ICU/hospital discharge, whichever occurs first
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