Early Dexmedetomidine and Sympathetic Regulation in Sepsis (DEX-SNS-SEPSIS)

March 10, 2026 updated by: Rongan Liu, Sichuan Academy of Medical Sciences

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine
Drug: Dexmedetomidine (DEX)
0.5 micrograms per kilogram per hour (0.5 μg/kg/h)
Placebo Comparator: ARM1
Drug: Placebo
0.9% Sodium Chloride Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From enrollment to the end of treatment at 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 48 hours
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
From enrollment to the end of treatment at 48 hours
ICU length of stay
Time Frame: From enrollment to ICU discharge or 90 days, whichever occurs first
Duration of ICU stay for each participant
From enrollment to ICU discharge or 90 days, whichever occurs first
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.
From randomization until successful liberation from mechanical ventilation, assessed up to 28 days.
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.
From randomization to 28 days after randomization.
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
From enrollment to the end of treatment at 48 hours
Procalcitonin (PCT) clearance
Time Frame: From enrollment to the end of treatment at 48 hours
Percentage change in PCT levels relative to baseline
From enrollment to the end of treatment at 48 hours
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
From enrollment to 28 days
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
From enrollment to 90 days
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
From enrollment to 90 days or ICU/hospital discharge, whichever occurs first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB No. 927-1 (2025)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe