Effects of Dexmedetomidine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock

Sponsor
First Affiliated Hospital of Wannan Medical College
Study ID
NCT07657715
Status
Not Yet Recruiting

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Conditions

  • Critical Illness
  • Sepsis
  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexmedetomidine Intravenous Infusion — DRUG
    Dexmedetomidine will be administered as a continuous intravenous infusion at 0.2-0.7 µg/kg/hour without a loading dose. The infusion rate may be adjusted according to the target sedation level, heart rate, mean arterial pressure, vasopressor requirement, PiCCO-derived hemodynamic variables, and adverse effects. Dose reduction, temporary interruption, or discontinuation is permitted for safety reasons, including clinically significant hypotension, bradycardia, new-onset or worsening arrhythmia, high-grade atrioventricular block, suspected myocardial ischemia, increased vasopressor requirement, or other clinically significant adverse events. The actual dose, infusion duration, and reasons for dose adjustment or discontinuation will be recorded.

Study Details

This prospective, multicenter, single-arm, open-label interventional pilot study aims to evaluate the short-term physiological effects of intravenous dexmedetomidine on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock. Eligible patients will have septic shock according to Sepsis-3 criteria, require norepinephrine support after adequate fluid resuscitation, receive invasive mechanical ventilation, and have PiCCO-based hemodynamic monitoring available before dexmedetomidine initiation. After baseline assessment, participants will receive intravenous dexmedetomidine according to the study protocol. Dexmedetomidine will be administered as a continuous intravenous infusion at 0.2-0.7 µg/kg/hour without a loading dose. The infusion rate may be adjusted according to the target sedation level, hemodynamic status, and adverse effects. Sublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline, 3 hours, and 6 hours after initiation of dexmedetomidine. Systemic hemodynamic, perfusion, vasopressor, PiCCO-derived, sedation-related, and safety outcomes will also be collected. The primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after dexmedetomidine administration and to provide preliminary data for future controlled studies.

Key Dates

First listed
Jun 18, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Dexmedetomidine Arm
    Adult patients with septic shock receiving invasive mechanical ventilation, norepinephrine support, and PiCCO-based hemodynamic monitoring after initial resuscitation will receive intravenous dexmedetomidine. Sublingual microcirculatory, vascular-waterfall, PiCCO-derived, macrocirculatory, perfusion, sedation-related, and safety variables will be assessed at baseline, 3 hours, and 6 hours after dexmedetomidine initiation.

Primary Outcome Measure

Change From Baseline in Pcc-Pmsf Gradient [ Time Frame: Baseline, 3 hours, and 6 hours after initiation of dexmedetomidine ]

Central Contacts

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