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Early Dexmedetomidine and Sympathetic Regulation in Sepsis

ConditionsSepsisSeptic Shock
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Academy of Medical Sciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine (DEX)

    Drug

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

  • Placebo

    Drug

    0.9% Sodium Chloride Injection

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: ARM1Placebo comparator 1 intervention
Group B: DexmedetomidineActive comparator 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

Change in Sequential Organ Failure Assessment (SOFA) Score

The change in Sequential Organ Failure Assessment (SOFA) score from baseline to 48 hours will be used to evaluate organ dysfunction.

Time frame
From enrollment to the end of treatment at 48 hours
2

Interleukin-6 (IL-6) level

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

Time frame
From enrollment to the end of treatment at 48 hours
3

ICU length of stay

Duration of ICU stay for each participant

Time frame
From enrollment to ICU discharge or 90 days, whichever occurs first
4

Duration of Mechanical Ventilation

Total duration of invasive mechanical ventilation during the first 48 hours after enrollment.

Time frame
From randomization until successful liberation from mechanical ventilation, assessed up to 28 days.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: