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

Sponsor
First Affiliated Hospital of Wannan Medical College
Study ID
NCT07657702
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

  • Anisodamine intravenous infusion — DRUG
    Anisodamine will be administered as an intravenous loading dose of 0.5 mg/kg within 3 minutes, with a minimum dose of 20 mg and a maximum dose of 40 mg, followed by continuous intravenous infusion at 0.02-0.1 mg/kg/hour. The maximum total daily dose will be 200 mg. The maintenance dose may be adjusted according to microcirculatory status, serum lactate level, capillary refill time, mean arterial pressure, heart rate, PiCCO-derived hemodynamic variables, vasopressor requirement, and adverse effects. Dose reduction, temporary interruption, or discontinuation is permitted for safety reasons, including clinically significant hypotension, excessive tachycardia, new-onset or worsening arrhythmia, prolonged QT interval, suspected myocardial ischemia, mental status changes, urinary retention, ileus, 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 anisodamine on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock. Eligible patients will have septic shock according to Sepsis-3 criteria, will require norepinephrine support after adequate fluid resuscitation, and will be receiving invasive mechanical ventilation and PiCCO-based hemodynamic monitoring. After baseline assessment, participants will receive intravenous anisodamine according to the study protocol. Anisodamine will be administered as a loading dose of 0.5 mg/kg within 3 minutes, with a minimum dose of 20 mg and a maximum dose of 40 mg, followed by continuous infusion at 0.02-0.1 mg/kg/hour, with a maximum total daily dose of 200 mg. 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 anisodamine. Systemic hemodynamic, perfusion, vasopressor, PiCCO-derived variables, and safety outcomes will also be collected. The primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after anisodamine 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: Anisodamine arm
    Adult patients with septic shock receiving invasive mechanical ventilation, norepinephrine support, and PiCCO-based hemodynamic monitoring after initial resuscitation will receive intravenous anisodamine. Sublingual microcirculatory, vascular-waterfall, PiCCO-derived, macrocirculatory, perfusion, and safety variables will be assessed at baseline, 3 hours, and 6 hours after anisodamine initiation.

Primary Outcome Measure

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

Central Contacts

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