A Prospective Study on the Effects of Early Dexmedetomidine Administration on Sympathetic Nervous System Activity, Pathophysiological Mechanisms, and Clinical Outcomes in Sepsis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 168
- 主要终点
- Heart Rate Variability (HRV)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 year Septic shock defined by Sepsis-3 criteria Enrollment within 24 hours of diagnosis APACHE II score > 10
排除标准
- •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
研究组 & 干预措施
ARM1
干预措施: Placebo (Drug)
Dexmedetomidine
干预措施: Dexmedetomidine (DEX) (Drug)
结局指标
主要结局
Heart Rate Variability (HRV)
时间窗: From enrollment to the end of treatment at 48 hours
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).
次要结局
- Change in Sequential Organ Failure Assessment (SOFA) Score(From enrollment to the end of treatment at 48 hours)
- Interleukin-6 (IL-6) level(From enrollment to the end of treatment at 48 hours)
- ICU length of stay(From enrollment to ICU discharge or 90 days, whichever occurs first)
- Duration of Mechanical Ventilation(From randomization until successful liberation from mechanical ventilation, assessed up to 28 days.)
- Requirement for Renal Replacement Therapy (RRT)(From randomization to 28 days after randomization.)
- Tumor necrosis factor-α (TNF-α) level(From enrollment to the end of treatment at 48 hours)
- Procalcitonin (PCT) clearance(From enrollment to the end of treatment at 48 hours)
- 28-day all-cause mortality(From enrollment to 28 days)
- 90-day all-cause mortality(From enrollment to 90 days)
- Incidence of new-onset organ dysfunction(From enrollment to 90 days or ICU/hospital discharge, whichever occurs first)
研究者
Rongan Liu
Associate Chief Physician, Intensive Care Unit
Sichuan Academy of Medical Sciences