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NCT Number: NCT07470775

Early Dexmedetomidine and Sympathetic Regulation in Sepsis

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine (DEX)

Drug

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

Placebo

Drug

0.9% Sodium Chloride Injection

Primary outcomes

  1. 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

  1. Change in Sequential Organ Failure Assessment (SOFA) Score

    Time frame: 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.

  2. Interleukin-6 (IL-6) level

    Time frame: From enrollment to the end of treatment at 48 hours

    Change in plasma IL-6 levels from baseline to 48 hours

  3. ICU length of stay

    Time frame: From enrollment to ICU discharge or 90 days, whichever occurs first

    Duration of ICU stay for each participant

  4. Duration of Mechanical Ventilation

    Time frame: 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.

  5. Requirement for Renal Replacement Therapy (RRT)

    Time frame: From randomization to 28 days after randomization.

    Number of participants requiring renal replacement therapy during the first 48 hours after enrollment.

  6. Tumor necrosis factor-α (TNF-α) level

    Time frame: From enrollment to the end of treatment at 48 hours

    Change in plasma TNF-α levels from baseline to 48 hours

  7. Procalcitonin (PCT) clearance

    Time frame: From enrollment to the end of treatment at 48 hours

    Percentage change in PCT levels relative to baseline

  8. 28-day all-cause mortality

    Time frame: From enrollment to 28 days

    Proportion of participants who die from any cause within 28 days of enrollment

  9. 90-day all-cause mortality

    Time frame: From enrollment to 90 days

    Proportion of participants who die from any cause within 90 days of enrollment

  10. Incidence of new-onset organ dysfunction

    Time frame: From enrollment to 90 days or ICU/hospital discharge, whichever occurs first

    Number of participants developing new organ dysfunction during the study period

Study contacts

Contact information is provided by the study sponsor or research team.

rongan Liu

CONTACT

[email protected]

+8615928731511

Sponsors and collaborators

Lead sponsor

Sichuan Academy of Medical Sciences

Other

Registry information

Official study title

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

Acronym: DEX-SNS-SEPSIS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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