Sepsis, Septic Shock
Conditions
Keywords
Dexmedetomidine, Sympathetic Nervous System, Septic Shock
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
Interventions
0.5 micrograms per kilogram per hour (0.5 μg/kg/h)
DRUGPlacebo
0.9% Sodium Chloride Injection
Sponsors
Sichuan Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability (HRV) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Sequential Organ Failure Assessment (SOFA) Score | From enrollment to the end of treatment at 48 hours | The change in Sequential Organ Failure Assessment (SOFA) score from baseline to 48 hours will be used to evaluate organ dysfunction. |
| Interleukin-6 (IL-6) level | From enrollment to the end of treatment at 48 hours | Change in plasma IL-6 levels from baseline to 48 hours |
| ICU length of stay | From enrollment to ICU discharge or 90 days, whichever occurs first | Duration of ICU stay for each participant |
| Duration of Mechanical Ventilation | From randomization until successful liberation from mechanical ventilation, assessed up to 28 days. | Total duration of invasive mechanical ventilation during the first 48 hours after enrollment. |
| Requirement for Renal Replacement Therapy (RRT) | From randomization to 28 days after randomization. | Number of participants requiring renal replacement therapy during the first 48 hours after enrollment. |
| Tumor necrosis factor-α (TNF-α) level | From enrollment to the end of treatment at 48 hours | Change in plasma TNF-α levels from baseline to 48 hours |
| Procalcitonin (PCT) clearance | From enrollment to the end of treatment at 48 hours | Percentage change in PCT levels relative to baseline |
| 28-day all-cause mortality | From enrollment to 28 days | Proportion of participants who die from any cause within 28 days of enrollment |
| 90-day all-cause mortality | From enrollment to 90 days | Proportion of participants who die from any cause within 90 days of enrollment |
| Incidence of new-onset organ dysfunction | From enrollment to 90 days or ICU/hospital discharge, whichever occurs first | Number of participants developing new organ dysfunction during the study period |
Contacts
CONTACTrongan Liu
Outcome results
None listed