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Early Dexmedetomidine and Sympathetic Regulation in Sepsis

NCT07470775 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-03-13

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine (DEX)

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

DRUG

Placebo

0.9% Sodium Chloride Injection

Sponsors & Collaborators

  • Sichuan Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-03-01
Completion
2028-03-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07470775 on ClinicalTrials.gov