A Prospective Study on the Effects of Early Dexmedetomidine Administration on Sympathetic Nervous System Activity, Pathophysiological Mechanisms, and Clinical Outcomes in Sepsis
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 168
- Primary Endpoint
- Heart Rate Variability (HRV)
Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 year Septic shock defined by Sepsis-3 criteria Enrollment within 24 hours of diagnosis APACHE II score \> 10
Exclusion Criteria
- •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
Arms & Interventions
ARM1
Intervention: Placebo (Drug)
Dexmedetomidine
Intervention: Dexmedetomidine (DEX) (Drug)
Outcomes
Primary Outcomes
Heart Rate Variability (HRV)
Time Frame: 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).
Secondary Outcomes
- 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)
Investigators
Rongan Liu
Associate Chief Physician, Intensive Care Unit
Sichuan Academy of Medical Sciences