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NOT YET RECRUITING
NCT07470775
PHASE4

Early Dexmedetomidine and Sympathetic Regulation in Sepsis

Sponsor: Sichuan Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

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

Official title: A Prospective Study on the Effects of Early Dexmedetomidine Administration on Sympathetic Nervous System Activity, Pathophysiological Mechanisms, and Clinical Outcomes in Sepsis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2026-03-01

Completion Date

2028-03-01

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Dexmedetomidine (DEX)

0.5 micrograms per kilogram per hour (0.5 μg/kg/h)

DRUG

Placebo

0.9% Sodium Chloride Injection