Early Dexmedetomidine and Sympathetic Regulation in Sepsis

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Sepsis, Septic Shock

In brief

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

Key facts

Study ID: NCT07470775
Run by: Sichuan Academy of Medical Sciences
People needed: 168
Starts: 2026-03-01
Expected to finish: 2028-03-01
Last updated by the study team: 2026-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 18 year Septic shock defined by Sepsis-3 criteria Enrollment within 24 hours of diagnosis APACHE II score > 10

You may not qualify if…

Pregnancy or lactation Second- or third-degree atrioventricular block Persistent bradycardia (HR <50 bpm) requiring intervention Hypersensitivity to dexmedetomidine Norepinephrine dose >0.5 μg/kg/min End-stage disease or life expectancy <72 hours Any condition deemed unsuitable by the investigator

Full record on ClinicalTrials.gov

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