Early Dexmedetomidine and Sympathetic Regulation in Sepsis

NCT07470775 | Not Yet Recruiting Phase 4

• 1 other identifier: IRB No. 927-1 (2025)
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

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

Conditions

Sepsis; Septic Shock

Keywords

Dexmedetomidine; Sympathetic Nervous System; Septic Shock

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability (HRV)

  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).

  From enrollment to the end of treatment at 48 hours

Secondary Outcomes (10)

• 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.

Study Arms (2)

ARM1

PLACEBO COMPARATOR

Drug: Placebo

Dexmedetomidine

ACTIVE COMPARATOR

Drug: Dexmedetomidine (DEX)

Interventions

Dexmedetomidine (DEX) DRUG

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

Dexmedetomidine

Placebo DRUG

0.9% Sodium Chloride Injection

ARM1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sichuan Academy of Medical Sciences: lead

Related Publications (22)

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MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

rongan Liu

CONTACT

+8615928731511; 35279240@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Intensive Care Unit

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share